Catalog Number UNK HIP FEMORAL HEAD METAL |
Device Problem
Naturally Worn (2988)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
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Event Date 01/01/2023 |
Event Type
Injury
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Event Description
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Litigation records ad (b)(6) 2023 alleges patient suffered of heavy metal poisoning from the toxic heavy metals released by the pinnacle hip replacement, resulting in injury decreased longevity, including but not limited to significant pain, bone destruction, metal wear, and toxic heavy metal poisoning, moreover, incurred medical expenses and expects to experience emotional distress.Doi: 2008 dor: (b)(6) 2022 affected side: right hip.
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Manufacturer Narrative
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Product complaint #: (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.E3 initial reporter occupation: lawyer 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.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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Search Alerts/Recalls
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