Catalog Number UNK KNEE FEMORAL ADAPTOR BOLT |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 10/31/2022 |
Event Type
Injury
|
Event Description
|
Patient was revised due to loosening of the unknown component at the bone to cement, cement to implant and bone to implant interface.Cement manufacturer was unknown.It was also reported that the tc3 femur appeared to have come loose from the femoral sleeve or adapter on x-ray.Once in the surgery it became apparent that the bolt was loose.Surgeon could not disassociate the adapter from the sleeve, so the entire femoral construct had to be removed.Surgeon would like the implant to be analyzed to find out why the bolt came loose.Doi: unknown.Dor: (b)(6) 2022.Affected side: unknown.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
|
|
Search Alerts/Recalls
|
|