Model Number N/A |
Device Problems
Unstable (1667); Insufficient Information (3190)
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Patient Problems
Pain (1994); Fibrosis (3167); No Information (3190)
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Event Date 04/26/2016 |
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.(b)(4).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 having difficulty moving around.A revision surgery is scheduled.
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Manufacturer Narrative
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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 was revised due to pain and loosening.
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Manufacturer Narrative
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No product was returned; therefore, the condition of the trabecular metal (tm) tibial implant is unknown and visual and dimensional evaluations could not be performed.The device history records for product part and lot combination were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.The knee compatibility matrix was reviewed and identified that all the components were 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.The patient required deep medial collateral ligament release to facilitate acceptable extension and flexion.After implementation of the final components, range of motion and stability were found to be excellent with well-balanced gaps and acceptable tracking of the patella.No-intra-operative complications were noted.The revision surgical notes state that the patient was revised for mechanical loosening of the recalled tibial component.Surgeon reported that the backside of the tibial component had 50% bony ingrowth and the remaining appeared fibrous.A field action was conducted on (b)(6) 2015 in which zimmer voluntarily removed the persona tm 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 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.
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Search Alerts/Recalls
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