Catalog Number UNK HIP ACETABULAR LINER |
Device Problem
Metal Shedding Debris (1804)
|
Patient Problems
Host-Tissue Reaction (1297); Unspecified Infection (1930); Tissue Damage (2104); No Information (3190)
|
Event Type
Injury
|
Manufacturer Narrative
|
This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Update sep 6, 2017: litigation received.Litigation alleges metallic particles in the patient's blood.It was stated that the estimated revision of the right hip is scheduled in (b)(6) 2017 to prevent the same infection and blood poisoning as occurred in his left hip.There are no medical records provided.This complaint was updated on.Sep 26, 2017.
|
|
Manufacturer Narrative
|
No device associated with this report was received for examination.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
No device associated with this report was received for examination.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Ppf alleges constrained liner, loosening of cup, infection, metal wear/metallosis and elevated metal ions.Patient harm and patient name were updated and added date of birth of the patient.Unknown cup and liner were added to the impacted product due to alleges infection and loosening of the cup.No revision reported.Date of implant was updated to (b)(6) 2004, from (b)(6) 2006.
|
|
Manufacturer Narrative
|
Product complaint # : (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|