Model Number 1035-41-000 |
Device Problem
Difficult to Insert (1316)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/12/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product complaint # (b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.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.
|
|
Event Description
|
It was reported that 41mm bipolar shell was used during implanting.Upon securing the bipolar shell to the femoral head implant, surgeon noticed a gap between these 2 implants which does not typically happen in other bipolar cases.Surgeon decided to test the same using a bipolar shell of a different size (42mm), and a different femoral head implant of the same size.The same test was conducted upon implanting and the bipolar shell still lifted off the femoral head implant.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Question: did the revision surgery happened? if yes, please provide the explant date.Answer: there was no revision surgery for this case.
|
|
Manufacturer Narrative
|
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: a manufacturing record evaluation (nc search) was performed, for the finished device 103541000, lot#: jt5183.And no non-conformances/manufacturing irregularities were identified.
|
|
Search Alerts/Recalls
|
|