Catalog Number 151640705 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Pain (1994); Joint Dislocation (2374)
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Event Date 03/27/2024 |
Event Type
Injury
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Event Description
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Pain and implant dislocation.It was reported that a revision is needed.
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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 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report 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.Removed patient code: joint dislocation.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 delay.B.Can you please specify which implant was dislocated? -no implant dislocation.C.Did the tibial insert dislocate from the tibial tray or did the insert dislocate from the femoral component.-the insert was in place.D.Did the tibial insert come all the way out of the tray (dislocation) or did it partially come out of the tray? -(spin-out) the insert has been forcibly removed from the tibial implant.No dislocation.
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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 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 records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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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