ENCORE MEDICAL L.P. STAR, SLIDING CORE, UHMPWE, 8MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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Catalog Number 400-142F |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/07/2023 |
Event Type
Injury
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Manufacturer Narrative
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Notes to form 3500a and justification for information not provided as required per 21cfr803.52 is below.Trilliant surgical attempted to obtain the omitted information (items 1-10 below) as part of internal complaint handling activities.Serial/lot # (d4) used in surgery unknown.Information not provided is not available to the reporter expiration date (d4) unknown as lot # could not be confirmed.Information not provided is not available to the reporter preprocessor name and address (d7) n/a to this report.Device 510k is unknown section g7 n/a to this report.Section h9 n/a to this report.No files attached to this report.Nvestigation on 12/07/2023, enovis customer care received a delivered goods form (dgf) for a star total ankle revision case, allegedly due to wearing of the poly due to the patient dislocating their ankle several years ago secondary to rheumatoid arthritis.There were 7 similar complaints identified for star poly component damage.The previous complaints do not aid in the investigation for this complaint, (b)(4).Dhr review was not conducted due to the complaint part not being returned and the lot number remaining unknown.The poly was not returned to the houston site, so visual and dimensional inspection did not occur.Simulated use testing did not occur.Per the reporter, the poly was "was worn down due to the patient dislocating their ankle several years ago secondary to rheumatoid arthritis." based on the limited information and the poly not being returned to the houston site, the root cause shall remain as unknown.
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Event Description
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On (b)(6) 2023, enovis customer care received a delivered goods form (dgf) for a star total ankle revision case, allegedly due to wearing of the poly due to the patient dislocating their ankle several years ago secondary to rheumatoid arthritis.
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Search Alerts/Recalls
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