Model Number 1218-87-456 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).Initial reporter occupation: lawyer.Follow-up is being conducted to determine the legal contact information.(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 medical records received.After review of medical records the patient was revised to addressed failed left total hip arthroplasty secondary to metallosis.Operative notes indicated pain, trochanteric bursitis, muscle weakness, leg length discrepancy, erosion at the head and neck junction.Results for cobalt-chromium shows below 7ppb.Doi: (b)(6) 2010 - dor: (b)(6) 2020 (left hip).
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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 device manufacturing (mre) review will not be performed even when product/lot information is known.Per wi-3430 it has been determined that, for the mom platform and related allegations an mre is not required.
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Search Alerts/Recalls
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