STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5532-G-613 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Unspecified Infection (1930); Injury (2348); Inadequate Osseointegration (2646)
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Event Date 11/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: triathlon p/a ps beaded #5l; cat # 5516f501; lot # ahs9s.Titanium bplate triathlon s6; cat # 5536b600; lot # ctd7479.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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Event Description
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Index and revision.Postoperative diagnosis: the patient underwent left total knee arthroplasty (b)(6) 2015.Patient had mechanical complication with loose patella polyethylene implant, the patellar component was removed and the liner was exchanged (b)(6) 2018.Reported as cors per 5171 knee.Patient underwent left total knee revision for pji with all components exchanged in (b)(6) 2019.
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Search Alerts/Recalls
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