Model Number 1217-32-058 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Scar Tissue (2060); Distress (2329); Discomfort (2330); Depression (2361); Osteolysis (2377); Ambulation Difficulties (2544); Fibrosis (3167); Joint Laxity (4526); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Date 02/09/2022 |
Event Type
Injury
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Event Description
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Pinnacle mom litigation records received.Litigation alleges heavy metal poisoning due to elevated metal ions resulting to injury to the muscles, tissues, metallosis, scar tissue formation, limited adl, emotional trauma, distress and pain.Doi: (b)(6) 2009; dor: (b)(6) 2022; hip unknown.
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Manufacturer Narrative
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Product complaint # (b)(4).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: the device associated with this report was not returned to depuy synthes for evaluation.Visual inspection of the x-ray evidence provided found nothing indicative of a device nonconformance.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 record evaluation was performed for the finished device (121732058/dk5d51) product and lot numbers, and no non-conformances were identified.Device history review: a manufacturing record evaluation was performed for the finished device (121732058/dk5d51) product and lot numbers, and no non-conformances were identified.
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Search Alerts/Recalls
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