STRYKER GMBH UNKNOWN REMOTION WRIST CARPAL PLATE; PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED
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Catalog Number UNK_SEL |
Device Problems
Loss of Osseointegration (2408); Naturally Worn (2988)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 11/24/2023 |
Event Type
Injury
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Manufacturer Narrative
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This complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged event of ¿revision surgery¿ could not be confirmed, since no additional information was received from the author or the article.More detailed information about the patient medical history, the event circumstances, and medical reports must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.H3 other text : device disposition is unknown.
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Event Description
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The manufacturer became aware of a published article titled ¿long-term results and explant analysis of the remotion total wrist arthroplasty¿.Allegedly, the author indicated that (1) patient experienced late aseptic loosening that were successfully revised to motec twas 16 years postoperatively.The report states ¿the two implants revised for aseptic loosening are shown.Neither specimen showed major or catastrophic wear; however, both explants showed multidirectional scratches on the articulating surface of the radial plate and concentric scratches on the carpal plate.There were also concentric scratches observed on the backside of the polyethylene insert¿.
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