Model Number 1363-45-000 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2021 |
Event Type
malfunction
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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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It was reported that the depuy sticker was attached directly to the femoral head implant instead of the blue plastic it is supposed to be attached to.Implant was immediately removed from sterile field and a new implant was opened.Surgery time was extended by 2 minutes.
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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.Although reportedly taken, no photographic images were provided.The device manufacturing record has been reviewed with no deviations or anomalies found.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: a manufacturing record evaluation was performed for the finished device (lot number: d19061730), and no non-conformances / manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device (lot number: d19061730), and no non-conformances / manufacturing irregularities were identified.
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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: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: g1 and h3.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary visual examination of the returned device found nothing indicative of a device nonconformance.The investigation cannot confirm the reported allegation with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot a manufacturing record evaluation was performed for the finished device (lot number: d19061730), and no non-conformances / manufacturing irregularities were identified.Device history review a manufacturing record evaluation was performed for the finished device (lot number: d19061730), and no non-conformances / manufacturing irregularities were identified.H10 additional narrative: added: a1, a2 (age) and a3 corrected: h3.
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Search Alerts/Recalls
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