Catalog Number UNK HIP |
Device Problems
Material Twisted/Bent (2981); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Rheumatoid Arthritis (1724); Edema (1820); Foreign Body Reaction (1868); Pain (1994); Thyroid Problems (2102); Injury (2348); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 01/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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(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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Event Description
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Pinnacle litigation received.Litigation alleges pain, rheumatoid arthritis, fibromyalgia, thyroid disease, inflammatory issues, metallosis, pain caused by lumbar radiculopathy, injury and disability, lack of mobility, emotional distress, increased lucency suggestive of a loosened stem, depression, anxiety, and elevated metal ions.After review of medical records, patient was revised to address failed implants.The proximal femoral endosteum had a quite a bit of fibrous tissue which was thoroughly cleaned.The anterior most screw was slightly stripped.When the screws came out with two turns, it became completely stripped.The posterior screw was removed with ease.Doi: (b)(6) 2008; dor: (b)(6) 2018; right hip.
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Manufacturer Narrative
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It was reported that one of the screws became stripped but is unknown which of the two reported screws was stripped so an unknown hip implant was added to capture the allegation.The 2 part#s of the screws are 121725500 and 121750500.This complaint will be updated once additional information is received confirming the exact device that was stripped.
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Manufacturer Narrative
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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.H10 additional narrative: 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Additional narrative: 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.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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Search Alerts/Recalls
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