Catalog Number 42530008301 |
Device Problems
Failure To Adhere Or Bond (1031); Osseointegration Problem (3003); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Inadequate Osseointegration (2646)
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Event Date 07/11/2016 |
Event Type
Injury
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Manufacturer Narrative
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Information was received from a consumer who is not required to complete form 3500a.This report will be amended when our investigation is complete.
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Event Description
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It is reported that the patient is experiencing pain and issues with the implant.The patient's surgeon has advised a revision.
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Manufacturer Narrative
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This report will be amended when our investigation is complete.Product received but not yet evaluated.
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Event Description
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It is further reported that the patient underwent revision knee arthroplasty surgery due to pain and loosening of the tibial component.
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Manufacturer Narrative
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Concomitant medical product - zimmer persona femoral component catalog #: 42502806801 lot #: 62859404, zimmer persona articular surface catalog #: 42512000611 lot #: 62842814, zimmer nexgen patellar component catalog #: 00587806541 lot # 62694103.This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.As received both devices exhibit signs of being implanted tm tray has foreign material in the tm and the pegs have been cut off.The device history records were reviewed for deviations and/ or anomalies with no deviations or anomalies identified.This device is used for treatment.Surgical notes were not provided; however, it was reported that the correct surgical technique was followed.Review of the implanted devices identified no compatibility issues.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.Fda recall z-1266-2015 contains the related tibial lot number.The capa investigation determined that the likely root causes for the higher than anticipated complaint rate is 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.
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Manufacturer Narrative
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This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
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Event Description
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It was reported that the patient's left hip was revised approximately one year post-implantation due to pain, tibial loosening and lack of bone ingrowth.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of the provided medical records.Evaluation.The surgery was indicated for mechanical loosening of the left knee.The pegs of the tibial baseplate were noted to having little to no bone ingrowth as well as 50% bone growth and 50% fibrous growth along the underside of the tibial baseplate.The additional information provided does not change the previously established root cause.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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Search Alerts/Recalls
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