Model Number 1035-40-000 |
Device Problems
Off-Label Use (1494); Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 03/21/2022 |
Event Type
Injury
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Event Description
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It was reported that this patient has a left total hip that is a recurrent dislocator.The surgeon revised the zimmer stem and changed the liner in our acetabulum.The pinnacle cup is well fixed and retained.The patient is stable now.There was no surgical delay.Doi: (b)(6) 2020; dor: (b)(6) 2022; affected side: left hip.
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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.
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Event Description
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Additional information was received indicating that "the patient had a pinnacle cup, a bipolar head implanted in a large depuy liner, along with competitor stem.The dislocation occurred between the bipolar self-centering component and the large liner.The pinnacle cup was retained.".
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
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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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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