Catalog Number UNK HIP FEMORAL STEM |
Device Problems
Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Rash (2033); Weakness (2145); Anxiety (2328); Deformity/ Disfigurement (2360); Depression (2361); Test Result (2695); No Code Available (3191); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.
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Event Description
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Asr xl litigation records received.Plaintiff alleges pain, rashes, memory loss, abnormal chromium level, metal poisoning, weakness, metallosis, metal debris, fear, anxiety, depression and disfigurement.Doi: (b)(6) 2006.Dor: none reported; right hip.
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Event Description
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After review of medical record, patient was revised to address large adverse local tissue reaction, increasing pain and swelling.Revision notes stated that synovial fluid was removed which was reddish black color.There was a bit of corrosion around the trunnion.There was metallosis in the acetabulum.
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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.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.Added: a2, (age,birth date), and h6 (patient).Corrected: h6 (device).
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the infections (e19).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Additional information received.Records alleged infection prior to revision.
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Search Alerts/Recalls
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