Biolox Delta Ceramic Head 32mm Standard Neck type 1 taper 에 대한 현장 안전성 서한

Field Safety Notice

2016-03-29

Slovenia

AMPMDRS

This notice is to inform you of an urgent field safety corrective action that has been initiated by biomet uk ltd which involves the biolox delta ceramic head implants referenced above. our records show that the implants may have been distributed to your hospital. we are requesting that you immediately locate and discontinue use of any implants with the above listed reference/lot number combinations. the ceramic heads are designed to be used with biomet femoral stems in total hip joint replacement surgery procedures comprising of a ceramic femoral head component articulating against either a ceramic insert fitted into a cementless acetabular shell or against ultra-high molecular weight polyethylene (uhmwpe) cups. biomet uk ltd has initiated this action following an investigation that has revealed that a product packaging labelled as biolox delta ceramic head 36mm standard neck type 12/14 taper (reference 650-0837/lot no. 2015051321) contained a biolox delta ceramic head 32mm standard neck type 1 taper, reference 650-1162 with serial number 5064122 engraved. review of internal records revealed that the biolox delta ceramic head 32mm standard neck type 1 taper with serial number 5064122 engraved, is used for the manufacturing of several lot numbers of reference 650-1162 biolox delta ceramic heads 32mm standard neck type 1 taper. the lot numbers 2015051327, 2015051328, 2015051329, 2015051214 were manufactured at at the same time as the biolox delta ceramic head 36mm standard neck type 12/14 taper (reference 650-0837/lot no. 2015051321). as it cannot be determined based on current available data which of the above 4 listed lots of the biolox delta ceramic head 32mm standard neck type 1 taper, reference 650 1162 contains a biolox delta ceramic head 36mm standard neck type 12/14 taper (reference 650-0837/lot no. 2015051321) biomet uk itd decided to recall all above listed lots as a precautionary measure. due to the ceramic heads having different size/angle tapers as well different head diameters, it is highly likely that this issue would be detected by the surgeon and theatre staff upon opening the box and checking the biolox delta ceramic head. in the unlikely event that it is not identified during the box opening process then the taper would not be compatible with the stem and the head would not fit to the liner correctly which would be very obvious to the surgeon. the most likely effect is therefore considered to be a delay to surgery whilst the surgeon sources another ceramic head. has initiated this action following an investigation that has revealed that a product packaging labelled as biolox delta ceramic head 36mm standard neck type 12/14 taper (reference 650-0837/lot no. 2015051321) contained a biolox delta ceramic head 32mm standard neck type 1 taper, reference 650-1162 with serial number 5064122 engraved. review of internal records revealed that the biolox delta ceramic head 32mm standard neck type 1 taper with serial number 5064122 engraved, is used for the manufacturing of several lot numbers of reference 650-1162 biolox delta ceramic heads 32mm standard neck type 1 taper. the lot numbers 2015051327, 2015051328, 2015051329, 2015051214 were manufactured at at the same time as the biolox delta ceramic head 36mm standard neck type 12/14 taper (reference 650-0837/lot no. 2015051321). as it cannot be determined based on current available data which of the above 4 listed lots of the biolox delta ceramic head 32mm standard neck type 1 taper, reference 650 1162 contains a biolox delta ceramic head 36mm standard neck type 12/14 taper (reference 650-0837/lot no. 2015051321) biomet uk itd decided to recall all above listed lots as a precautionary measure. due to the ceramic heads having different size/angle tapers as well different head diameters, it is highly likely that this issue would be detected by the surgeon and theatre staff upon opening the box and checking the biolox delta ceramic head. in the unlikely event that it is not identified during the box opening process then the taper would not be compatible with the stem and the head would not fit to the liner correctly which would be very obvious to the surgeon. the most likely effect is therefore considered to be a delay to surgery whilst the surgeon sources another ceramic head. .