STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 10MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 6481-3-210 |
Device Problem
Unstable (1667)
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Patient Problem
Joint Laxity (4526)
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Event Date 05/06/2022 |
Event Type
Injury
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Event Description
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The patient had a primary tka out of cors scope.The patient presented patellar clunk and instability due to hyperextension, so he underwent l tka revision on (b)(6) 2017, with an mrh system.The patient progressed well but developed instability again and underwent l tka revision on (b)(6) 2022.All rotating components plus the patella were exchanged.
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Manufacturer Narrative
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Reported event: an event regarding instability involving an mrh insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device 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 reported lot.Conclusion: it was reported that the patient was revised due to instability.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.The following devices were also listed in this report: device name#tri cemented stem 12mmx100mm ; cat#5560-s-212 ; lot#0045715j.Device name#mrhk femoral bushing ; cat#64812110 ; lot#lfj547.Device name#mrhk bumper insert 3 degrees ; cat#64812133 ; lot#lfg678.Device name#mrhk femoral bushing ; cat#64812110 ; lot#lfj547.Device name#mrhk tibial sleeve ; cat#64812140 ; lot#lfk885.Device name#mrh axle ; cat#64812120 ; lot#ctd11978a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : device not returned to the manufacturer.
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