DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,42 NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM
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Model Number 52-3393 |
Device Problem
Degraded (1153)
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Patient Problems
Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Pocket Erosion (2013); Tissue Damage (2104); No Code Available (3191)
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Event Date 04/22/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.(b)(4).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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Event Description
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Pinnacle claim submission form and medical records received.After review of medical records, the patient was revised to address a failed left total hip arthroplasty with pain and signs of metallosis.Operative findings include severe reactive metallosis, soft tissue damage, erosion, significant amount of wear on the surface of the head and black metallic appearing rust over the trunnion.Samples taken from a cyst and pseudotumor were sent to the laboratory for analysis.Preoperatively, the patient was slightly longer on the right.Doi: (b)(6) 2004; dor: (b)(6) 2016; right hip.
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Manufacturer Narrative
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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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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