DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR +4 NEUT 36IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
|
Back to Search Results |
|
Catalog Number 121936454 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Cardiac Arrest (1762); Infarction, Cerebral (1771); Tissue Damage (2104)
|
Event Date 01/01/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
|
|
Event Description
|
Ppf alleges pseudotumor, stroke/heart attack and elevated metal ions after first revision.After review of medical records, there were no revision notes provided or reported.Doi: (b)(6) 2009 (cup); doi: (b)(6) 2016 (head and liner); dor: none reported (left hip).
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|