(b)(4).Concomitant medical product: femur trabecular metal, item# 42502806601, lot# 64592715.Tibial augment cemented half block left lateral size ef 15 mm thickness, item# 42555805115, lot# 64628774.Tibial augment cemented half block left medial size ef 15 mm thickness, item# 42555805315, lot# 64630424.Stem extension tapered cemented 14 mm diameter +75 mm, item# 42560007514, lot# 64875941.Femur cemented standard left size 9, item# 42504606601, lot# 64890454.Stem extension tapered cemented 14 mm diameter +75 mm length, item# 42560007514, lot# 65047301.2.5 mm female hex screw 25 mm length, item# 42509902525, lot# 65130228.Hex headed screw 3.5 mm hex 48 mm length, item# 00590103548, lot# 64797688.Hex headed screw 3.5 mm hex 27 mm, item# 00590103527, lot# 64768589.Headless trocar drill pin 3.2 mm diameter 75 mm length, item# 00590102000, lot# 65019755.The product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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This follow-up is being submitted to relay additional information.Visual examination of the returned product identified signs of being implanted such as wear/discoloration and foreign material and the articular surface assembled to it.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: findings suggest loosening.Secondary to loosening, there is separation of the lateral tibial plate with respect to the lateral tibial plateau.This creates a gap between the hardware and bone.Questionable additional periprosthetic lucency without bone and hardware separation at the level of the medial tibial peg.Alignment otherwise appears normal.No additional findings of wear.Subsidence could be present but cannot be confirmed with a single time point.There is separation between the hardware and bone which is likely a new finding and likely related to subsidence, which would require prior time point to confirm (as subsidence is defined as movement of hardware over two separate time points).Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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