Catalog Number UNK-HIP |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
No Information (3190)
|
Event Date 10/21/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Depuy synthes has been informed that the catalog number and lot number is not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Patient was revised due to a peri prosthetic fracture.Additionally provided patient xrays and follow up information from the sales rep indicates the patient also dislocated.
|
|
Manufacturer Narrative
|
Patient was revised due to a peri prosthetic fracture.Additionally provided patient xrays and follow up information from the sales rep indicates the patient also dislocated.Examination of the reported devices was not possible as they were not returned.Review of provided patient xrays confirms dislocation of the femoral head.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.The investigation can draw no conclusion regarding the reported event with the information available.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed.Should additional information be received the investigation will be reopened.
|
|
Search Alerts/Recalls
|