STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5536B600 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); Swelling/ Edema (4577)
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Event Date 01/08/2024 |
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.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.
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Event Description
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Patient reported he is a disabled vet.In (b)(6) 2021, had a left knee replacement.Right after implantation, patient had fevers for a week.Patient also experienced swelling, pain, and infections.Patient consulted another doctor in (b)(6) 2023.A bone scan showed loosening (implant not specified but patient was focused on baseplate).Patient was told the baseplate was also recalled.Consulting surgeon referred patient to a specialist who performs revisions.Revision performed (b)(6) 2024.Patient reports he has incurred and is still incurring many medical bills, as well as having had pain and suffering but is in recovery.Patient is seeking compensation and stated he has not yet retained an attorney.
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Search Alerts/Recalls
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