Model Number 1035-48-000 |
Device Problem
Difficult to Insert (1316)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/18/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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
|
Polyethylene inlay in selfcentering metalhead is not stable and moves (also hearable).No patient harm - implant was not contact with patient.
|
|
Manufacturer Narrative
|
Product complaint # : pc-(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 search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : examination of the returned device could not confirm the reported event.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 search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
|
|
Search Alerts/Recalls
|