Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Unstable (1667); Insufficient Information (3190)
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Patient Problems
Pain (1994); Swelling (2091); No Code Available (3191)
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Event Date 09/26/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) concomitant medical products - unicompartmental knee system articular surface # 00584202408 lot # 62930002 unicompartmental knee system tibial component precoat # 00584200402 lot # 62967301.Multiple mdr reports were filed for this event, please see associated reports : 0001822565-2017-07280 and 0001822565-2017-07281.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the patient underwent a revision surgery approximately 2 years post initial knee surgery due to pain.
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Manufacturer Narrative
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Reported event was confirmed by review of operative notes and x-ray reviews.X-ray review indicates that the medial margin of the tibial component projects several millimeters medial to the medial margin of the native tibial plateau rather than overlying or overhanging the medial tibial plateau.The tibial component exhibits approximately 2° anterior slope rather than desirable posterior slope.There is a suggestion of subsidence of the tibial component anteriorly.Tibial component coronal alignment and femoral component alignment are unremarkable.The femoral component nears the tibial component suggesting possible wear thinning/wear of the polyethylene insert.Bone quality appears grossly normal.Thin linear radiolucency is present at the tibial component metal-bone interface anteriorly suspicious for loosening of the tibial component.Linear radiolucency at the femoral component metal-bone and metal-soft tissue interfaces favors rebound artifact.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.Per package insert unicompartmental knee pain, swelling, instability are known adverse effects of the tka procedure.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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It was reported that the patient underwent a uni-compartmental knee arthroplasty revision surgery approximately two (2) years post initial knee surgery due to pain, instability, and swelling.The patient was revised to a total knee arthroplasty.
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Search Alerts/Recalls
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