STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR BASEPLATE #6 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 5620-B-601 |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Injury (2348); Inadequate Osseointegration (2646)
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Event Date 08/04/2015 |
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 information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
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Event Description
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It was reported through the communication of an attorney that allegedly the patient was revised due to "aseptic loosening, combined patellofemoral medial compartment arthroplasty, left knee.".
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Search Alerts/Recalls
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