Model Number N/A |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Failure of Implant (1924); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Implant Pain (4561); Swelling/ Edema (4577)
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Event Date 02/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant devices - unknown persona partial knee tibial component catalog #: ni lot #: ni, unknown persona partial knee femoral component catalog #: ni lot #: ni.Report source - foreign: (b)(6).The complainant has indicated that the product will be returned once revised to zimmer biomet for investigation.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 is scheduled to undergo a knee arthroplasty revision to address pain and loss of mobility a few years post-operatively.Attempts have been made, however, no additional information can be provided at this time.
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Event Description
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It is reported that the patient underwent a right knee arthroplasty revision to address pain, swelling, warmth of the knee and loss of mobility approximately four (4) years post-operatively.Initial operative notes did not identify any intraoperative complications.Revision operative notes noted that the components were well-fixed, but that the polyethylene bearing was worn.Attempts have been made, however, no additional information can be provided at this time.
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Manufacturer Narrative
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D10 - concomitant devices - persona partial knee cemented femoral component size 5 right medial catalog #: 42558000502 lot #: 63485124, persona partial knee tibial component catalog #: ni lot #: ni.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of use and worn.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates that ct scan exhibited increased accumulation in medial femoral condyle adjacent to the medial side of the femoral prosthetic component possibly indicating detachment.Patient continues to have pain, limping and swelling.Femoral was suspected to be loose however during the revision procedure the femur and tibia were found well fixed.Bearing was found worn.No complications noted.X-rays were provided and reviewed by a health care professional.Review found no signs of loosening.Overall fit and alignment are maintained.Bone quality is osteopenic.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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