STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CR #6 10MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5530-G-610-E |
Device Problem
Pitted (1460)
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Patient Problems
Bone Fracture(s) (1870); Osteolysis (2377)
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Event Date 10/29/2021 |
Event Type
Injury
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
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Event Description
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It was reported that the patient's left knee was revised due to tibial pain.Intra-operatively, the following were observed: osteolysis and fracture of the medial tibia, and the insert appeared to have been pitted.The baseplate and insert were revised.
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Manufacturer Narrative
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An event regarding wear involving a triathlon insert was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that it is worn in the area upon which the femoral condyles articulate.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to periprosthetic fracture and wear of the tibial insert which was observed intraoperatively.Visual inspection of the returned device indicated that it is worn in the area upon which the femoral condyles articulate.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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It was reported that the patient's left knee was revised due to tibial pain.Intra-operatively, the following were observed: osteolysis and fracture of the medial tibia, and the insert appeared to have been pitted.The baseplate and insert were revised.
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Search Alerts/Recalls
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