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Model Number N/A |
Device Problems
Disassembly (1168); Fracture (1260); Migration or Expulsion of Device (1395)
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Patient Problem
Pain (1994)
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Event Date 06/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical product: unknown tibial bearing catalog # unknown lot # unknown, unknown tibial component catalog # unknown lot # unknown.Product is not returned to zimmer biomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2018-00156, 0001822565-2018-00133.
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Event Description
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It was reported that the patient underwent a knee arthroplasty.Subsequently, patient underwent a revision procedure due to pain, disassembly, and fracture.
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Manufacturer Narrative
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Concomitant medical products: nexgen stemmed tibial component, catalog #: 00598003701, lot #: 62964726, palacos bone cement, catalog #: 00111214001, lot #: 80414394, nexgen lps-flex femoral component, catalog #: 00596401452, lot #: 60804231, nexgen all polyethylene patella, catalog #: 00597206532, lot #: 62884640, nexgen lps-flex articular surface, catalog #: 00596203012, lot #: 62510618.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 event, please see associated reports: 0001822565-2018-00133.0001822565-2018-00157.0002648920-2018-00164.
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Event Description
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It was reported a patient underwent right knee revision due to pain and tibial component loosening.During the procedure, separation of tibial component and cement was noted; no other significant loosening noted.All tibial components were revised.
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Manufacturer Narrative
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Upon reassessment of the reported event, this device was determined to be not reportable.After review of invoice history, this component was not removed during the revision procedure.
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Manufacturer Narrative
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Reported event was confirmed by review of operative notes.The revision surgical notes indicate that the patient underwent revision due to tibial loosening two years post-implantation.Intra-operatively the tibial component was found to be loose from the cement mantle, especially in the posterolateral region.No other significant loosening was noted.Dhr was reviewed and no discrepancies were found.Per the instructions for use, loosening of the prosthetic knee components is a known potential adverse effect of the tka procedure.Also, patient factors that may affect the performance of the components such as bone quality, activity level or type of activity are unknown.However, a definitive root cause cannot be determined.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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