Catalog Number UNK HIP FEMORAL STEM |
Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Scarring (2061); Tissue Damage (2104); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Date 05/12/2016 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint : (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Occupation: (b)(6).
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Event Description
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Litigation alleges the patient was implanted with a metal-on-metal pinnacle device and underwent a painful and risky revision surgery.Update ad 4 mar 2019: receipt of pfs and medical record.In addition to what was previously alleged, pfs alleges physical injuries, pain, popping sensation, walking difficulty, limited mobility and elevated metal ion levels in the blood.After review of medical records, it was stated that the patient was revised to address recurrent dislocation.Revision notes reported some yellowish fluid in the joint and metallosis areas, and scar and soft tissues with metal debris were removed.Pathology report noted synovial-like tissue with foreign body reaction to prosthetic wear debris.Lab report shows that metal ion levels were above 7 ppb.
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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.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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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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.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 null device history batch null device history review null 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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