Model Number 1010-11-060 |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/08/2022 |
Event Type
malfunction
|
Event Description
|
Sterile packaging was broken.This was discovered when box was opened.No surgical delay.Doi: (b)(6) 2022.Dor: (b)(6) 2022.Affected side: unknown hip.
|
|
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.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.Photographic evidence was provided and reviewed.Photo evidence shows inner plastic packaging tore.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: (b)(4).Pi-16496975238663722.Device history record review for: product description: actis collared std size 6.Product code: 101011060.Lot number: jr7386.Device history review: a manufacturing record evaluation was performed for the finished device (product code 101011060/lot jr7386) product and lot numbers, and no non-conformances were identified.
|
|
Search Alerts/Recalls
|