STRYKER ORTHOPAEDICS-MAHWAH MRHK BUMPER INSERT 3 DEGREES; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 64812133 |
Device Problems
Naturally Worn (2988); Insufficient Information (3190)
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Patient Problem
Injury (2348)
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Event Date 09/30/2019 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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It was reported that patient's right distal femur was revised due to wear and debris from the insert and sleeve.Surgeon has requested that an elemental analysis be performed on the devices, which will be returned.
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Event Description
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It was reported that patient's right distal femur was revised due to wear and debris from the insert and sleeve.Surgeon has requested that an elemental analysis be performed on the devices, which will be returned.
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Manufacturer Narrative
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An event regarding wear and debris from the insert and sleeve involving a mrh bumper insert was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event.It was reported that the patient was revised due to wear and debris from the insert and sleeve.Visual inspection of the device indicated that no indication to suggest a product non-conformity or unanticipated hazard.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Search Alerts/Recalls
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