Model Number 1217-12-054 |
Device Problems
Device Dislodged or Dislocated (2923); Noise, Audible (3273)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 03/29/2023 |
Event Type
Injury
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Event Description
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Primary surgery details.Hospital: (b)(6).Date: (b)(6) 2017.Patient: 80 yr old male (all patient details hospital is providing).Implants available for return: no - hospital have sent away for independent analysis.Revision surgery details.Hospital: (b)(6).Date: (b)(6) 2023.Reason for revision: poly liner had flipped out of cup (see image of pre-revision surgery x ray attached).Patient presented to clinic with squeaking.During revision surgery there was localised metallurgy where the head had rubbed against pinnacle cup.Cup, liner and head were revised and stem was left.
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Manufacturer Narrative
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Product complaint # (b)(4).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.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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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.H10 additional narrative: added: b5, d4 (expiration date), d10 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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Event Description
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Additional information received: a.Was there a surgical delay? if yes, what is the duration of the delay? no.This was planned revision surgery.B.Was all the reported products revised? no.The cup, liner, and head were revised and the stem was left.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-ray provided revealed disassociation, it is reasonable to confirm audible sound due to the unintended interaction between the components.The reported allegation can be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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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