STRYKER ORTHOPAEDICS-MAHWAH HMRS AXIS PIN; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 6366-9-220 |
Device Problems
Material Erosion (1214); Naturally Worn (2988)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/17/2022 |
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.Device not returned.
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Event Description
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Hmrs parts replacement after 12 years.The wear of the components was confirmed during the surgery.The parts have all been replaced as requested.Some poly parts were severely damaged or disassembled into individual parts due to the difficult disassembly.Due to wear and tear, it was suspected that replacing the components would be prudent.
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Manufacturer Narrative
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An event regarding wear involving a hmrs axle was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device is worn along the circumference of the barrel.Damage appears consistent with contact against a hard object.-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 wear of the components.Visual inspection of the returned device indicated that the device is worn along the circumference of the barrel.Damage appears consistent with contact against a hard object.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary/revision operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.It was reported that the patient was very active post-implantation.The patient's activity level may have contributed to the reported failure of the devices.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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Hmrs parts replacement after 12 years.The wear of the components was confirmed during the surgery.The parts have all been replaced as requested.Some poly parts were severely damaged or disassembled into individual parts due to the difficult disassembly.Due to wear and tear, it was suspected that replacing the components would be prudent.
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