Catalog Number 157011135 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)
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Event Date 11/02/2016 |
Event Type
Injury
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Manufacturer Narrative
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(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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Patient was revised due to pain.There was a tremendous amount of pelvic bone loss and necrotic tissue around the hip.Litigation alleges friction and wear between the metal head and liner caused the release of toxic metal ions and particles into the patient's body resulting to injury, discomfort, soreness, disfigurement, mental anguish, suffering, emotional distress and inability to perform normal daily activities.Doi: (b)(6) 2009; dor: (b)(6) 2016; right 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.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 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.Udi:(b)(4).
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Event Description
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Ppf alleges loosening of cup and metallosis.
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Search Alerts/Recalls
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