SMITH & NEPHEW, INC. UNKN SYNERGY HIP STEM UNCEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNKNOWN |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Failure of Implant (1924); Osteolysis (2377); Inadequate Osseointegration (2646)
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Event Date 07/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
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Event Description
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It was reported that on literature review "oxidized zirconium versus cobalt-chrome femoral heads in total hip arthroplasty: a multicentre prospective randomized controlled trial with ten years¿ follow-up", two (2) patients developed osteolysis and loosening of the femoral stem aproximately ten years after a tha surgery.The patients had a bearing combination of an oxinium femoral head and an uhmwpe liner.These adverse events were treated with a revision surgery.No further information is available.
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Manufacturer Narrative
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B1, h6 (clinical codes).
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Search Alerts/Recalls
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