Catalog Number 121881754 |
Device Problems
Fracture (1260); Noise, Audible (3273)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 09/29/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Breakage of the ceramic insert.Change of the prosthesis one year after implantation.
|
|
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.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: h3.
|
|
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
|
Additional information received indicated that an x-ray result revealed that there was a fracture of the ceramic either at the expense of the head or at the expense of the insert which is more probable.The noise noted was secondary to the implant fracture.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : the device associated with this report was returned to depuy synthes and sent to the manufacturing site which conducted a visual inspection of the returned device.Visual examination of the device confirmed the reported fractured event.The ceramic insert was found fractured into two large fragments and approximately ten or more small fragments.However, there is not enough evidence to determine if audible sound could be caused by the insert and another device.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 ceramic insert belongs to the shop order (b)(4).Protocols and acceptance certificate were reviewed.The quality documents show that the data obtained on the insert confirmed to the specification valid at the time of production.
|
|
Search Alerts/Recalls
|