ZIMMER BIOMET, INC. ZIMMER UNICOMPARTMENTAL KNEE ARTICULAR SURFACE SIZE 4 11MM; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problems
Pain (1994); Limited Mobility Of The Implanted Joint (2671)
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Event Date 02/22/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices - zimmer unicompartmental knee precoat tibial component size 4, catalog #: 00584200402, lot #: 61927336, zimmer unicompartmental knee high flex precoat femoral component, catalog #: 00584201602, lot #: 61928542, headed screw 48mm, catalog #: 00579104100, lot #: 62208598, headed screw 33mm, catalog #: 00579104400, lot #: 62203456.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.
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Event Description
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It is reported that the patient has been experiencing pain, popping in the knee and limited physical abilities approximately six (6) years following knee arthroplasty.No additional patient consequences have been reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.
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Event Description
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It is reported that the patient underwent a left knee arthroplasty revision to address pain, popping in the knee and limited physical abilities approximately six (6) years post-operatively.No additional patient consequences have been reported.
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Manufacturer Narrative
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The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies relevant to the reported event were identified.Per package insert for unicompartmental knees, pain, noise, and limited physical activity are known potential adverse effects associated with the surgical procedure.However, a definitive root cause could not be determined with the information provided.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event.0001822565-2019-00999, 0001822565-2019-04800, 0001822565-2019-04801.
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Event Description
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No further event information available at the time of this report.
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