SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Catalog Number 74122546 |
Device Problems
Material Integrity Problem (2978); Insufficient Information (3190)
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Patient Problems
Pain (1994); Toxicity (2333); Injury (2348); Test Result (2695)
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Event Date 07/21/2015 |
Event Type
Injury
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Event Description
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It was reported that left hip revision surgery was performed due to elevated metalo ion levels.Implanted (b)(6) 2009.
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Manufacturer Narrative
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It was reported that left hip revision surgery was performed due to elevated metal ion levels.During revision the hemi head and the modular sleeve were removed.The bhr cup and synergy stem remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.According to the provided revision report, the patient started having pain recently before the revision and had increased blood metal ions.The cup and stem were well fixed and the cup showed no wear spots and left in-vivo.Review of the provided surgical report did not indicate any inconsistencies with the surgical technique or other factors that could explain the reported findings.No additional information on the blood metal ions was provided.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
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Manufacturer Narrative
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Smith + nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith + nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith + nephew, or its employees, that the report constitutes an admission that the device, smith + nephew or its employees caused or contributed to the potential event described in this report.- attachment: [184595 summary.Pdf].
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