Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Osteolysis (2377); Physical Asymmetry (4573)
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Event Date 01/01/2022 |
Event Type
Injury
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Event Description
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Article entitled ¿aseptic loosening after total hip arthroplasty secondary to the disappearing coating?¿ written by m.Nie published in asian journal of surgery on october 12, 2021 was reviewed.44-year-old male patient underwent a l tha 4 years ago due to left hip ankylosis.The patient experienced pain in the left groin area one years ago.There was a shortening of the left leg of 2.5 cm.The gait was limping.A preoperative x-ray showed that the femoral stem had osteolysis around the prosthesis, and the femoral component subsided.The patient underwent a revision and femoral loosening was found.There were a large amount of inflammatory pseudomembrane in the femoral medullary cavity, and no bone ingrowth around the femoral stem.Implants: pinnacle cup, corail stem, ceramic head, and ceramic liner.
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Manufacturer Narrative
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Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary = > no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot = > a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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