Catalog Number 122132150 |
Device Problems
Fracture (1260); Material Separation (1562); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Injury (2348); No Code Available (3191)
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Event Date 02/13/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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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We have received an extrajudicial product liability claim on behalf of the patient a.B.F.The patient´s attorney claims that the patient was implanted with hip prosthesis pinnacle on (b)(6) 2017 and that it was explanted on (b)(6) 2019.
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Manufacturer Narrative
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Udi: (b)(4).
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Event Description
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The patient alleges noises or small jumps in the hip, pain and possible reason for revision is the broken insert as per previous rx.
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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.(corrected:h6(device codes) 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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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: added: a2 (dob), b5, b7 and h6 (patient and device codes).
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Event Description
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After review of medical records, patient was revised due aseptic loosening of thr.Operative note reported metallosis, lip wear and bone defect.The medical records did not clearly specify that the cup loose and the liner disassociated.But based on how the event was presented, it was likely that the cup loose since there was a bone defect in the acetabular bottom and there was a liner disassociation since it was reported as polyethylene breaking and loosening.
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Search Alerts/Recalls
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