Model Number 52-2029 |
Device Problem
Off-Label Use (1494)
|
Patient Problem
Joint Laxity (4526)
|
Event Date 04/08/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).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 the patient revised due to instability.Original implant date unknown.The patient had a competitor cup implanted with an srom stem.She removed a 28,+6 cocr srom head.She then put in a competitor liner with a 36,+9 srom cocr head.Patient hip was stable after this.Was not able to obtain lot numbers from head removed due to hospital protocols.Doi: unknown, dor: (b)(6) 2022, affected side: unknown.
|
|
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 (mre), was not possible because the required lot code was not provided.
|
|
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.
|
|
Search Alerts/Recalls
|
|