This report is being amended to reflect changes in adverse event and/or product problem, explant date, event problem codes, date received by mfr, type of reports, type of reportable event, if follow-up, what type?, evaluation codes, if remedial action initiated and additional mfr narrative.No devices or photographs were received with complaint for investigation; therefore, the condition of the persona two-peg trabecular metal (tm) tibia component is unknown.Without a device for exam, neither visual nor dimensional analysis are possible.The device history records review on the product part and lot numbers identified no deviations or anomalies.The knee component compatibility matrix was reviewed and identified that all components are compatible.This device is used for treatment.A complaint history search identified no other complaint for the part/lot combination of the tibial component.The primary surgical notes state that the patient underwent total knee arthroplasty (tka) to treat severe degenerative joint disease of the left knee.Bony cuts were performed, osteophytes removed, and the trial components were inserted.Release of the deep medial collateral ligament semimembranosus was required to achieve acceptable extension and flexion, well-balanced gaps, and excellent tracking of the patella.The final components were implemented using a cementless technique.Range of motion and stability were checked and found to be excellent with well-balanced gaps and acceptable patellar tracking.No intraoperative complication noted.The revision surgical notes state that the patient was revised 22 months after primary implantation to address the failure of the tka associated with the recall of the tibial component.Intra-operatively, the synovial fluid was clear.The tibial component was removed by using saws, 50% of the implant surface had the correct bony ingrowth while the remaining part was fibrous.The medial head (peg) was well fixed but not the lateral one.The femoral and patellar components were felt to be intact and left alone.A field action was conducted on february 19, 2015 in which zimmer voluntarily removed the persona trabecular metal tibial implant from the field due to a higher than anticipated complaint rate for radiolucent lines and loosening.The device in question was implanted prior to this field action.An fda recall contains the related tibial lot number.The corrective actions investigation determined that the likely root causes for the higher than anticipated complaint rate are that the persona tm tibia allows the potential for the tibial implant to sit proud on the resected tibial surface and the persona tm tibia has less initial stability than predicate devices.Therefore, the problem with this device constitutes a design issue as the root cause.
|
This follow-up report is being submitted to relay additional information.Concomitant medical product- femur trabecular metal cruciate retaining (cr) narrow porous catalog# 42502206001 lot# 62504834, nexgen® complete knee solution, trabecular metal standard primary patella catalog# 00587806532 lot# 62491597, articular surface fixed bearing cruciate retaining (cr) left 10 mm height catalog# 42512000510 lot# 62380346.The tibial tray were returned and examination of the returned parts determined that it has foreign material on the inferior surface.The two pegs were found fractured off, and the two peg fractured pieces were returned.The superior surface has a few scrapes and abrasions.There was some bone ingrowth across the inferior surface with areas where ingrowth had not taken place.Dhr was reviewed and no discrepancies relevant to the reported event were found.The additional information was reviewed and it does not change the previous conclusions.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.
|