Catalog Number UNK HIP ACETABULAR LINER METAL |
Device Problem
Naturally Worn (2988)
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Patient Problems
Fever (1858); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/06/2021 |
Event Type
Injury
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Event Description
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Pinnacle mom litigation records received.Litigation alleges revision due to heavy metal poisoning from toxic metals resulting to pain, pseudotumor, trunnionosis, tissue destruction, metal wear, loss of enjoyment of life, limited adl, emotional trauma and distress.Doi: (b)(6) 2006, dor: (b)(6) 2021, hip unknown.
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Manufacturer Narrative
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Product complaint # (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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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.Device history lot: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
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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.Device history lot - a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Event Description
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Medical records received.On (b)(6) 2021, the patient was revised due to right total hip revision femoral head and liner exchange possible acetabular revision.The patient has a long history of severe pain secondary to metallosis after a two-stage revision in 2006.The patient has a history of primary in 2004.After the revision of 2006, about 5 to 6 months the patient was evaluated and found to have pseudotumor confirmed in mri as well elevated metal ion levels.Prior to 2 days, the patient developed confusion and fever, found with staph bacteremia, with aspiration the right hip showed a gram-positive cocci growing from early cultures.Surgical noted trunnion was evaluated with metallosis at the grooves.The patient had previously infected hip arthroplasty in 2004 but it was an unknown manufacturer.These devices were replaced with a pinnacle hip in 2006.No implant stickers were provided for the dated right total arthroplasty on (b)(6) 2006.
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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.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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Medical records were received and stated the following: on (b)(6)2021: incision and drainage of shoulder deep abscess and hematoma with left shoulder myolitis with incomplete collection.On (b)(6)2021.Patient was revised due to right total hip arthroplasty painful metallosis with superimposed concern for periprosthetic infection.Also reported of cobalt poisoning.
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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.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-ray evidence found nothing indicative of a device nonconformance.No signs of implant bearing wear were observed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this 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.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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Affected side: right hip.
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Search Alerts/Recalls
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