UNKNOWN DEPUY ASR ACETABULAR CUP
Received Jul 21, 2017 · Event occurred Jun 22, 2017
Report 1818910-2017-21468 · MDR key 6731394
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
55 YR
- Foreign Body Reaction
- Pain
- No Code Available
- Foreign Body Reaction
- Pain
- No Code Available
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE DEVICE IS NOT CONTRIBUTING TO THE ISSUE THEREFORE THIS REPORT IS BEING REJECTED.
Additional 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.
Description of Event or Problem
ASR REVISION, LEFT, ASR HIP RESURFACING SYSTEM, REASON FOR REVISION: ELEVATED METAL ION LEVELS AND METALLOSIS, UPDATE JUN 22, 2017: LITIGATION RECEIVED. LITIGATION ALLEGES HIGH METAL IONS. IT WAS ALSO REPORTED THAT AFTER THE REVISION SURGERY, PATIENT IS STILL EXPERIENCING RESIDUAL PAIN, FREQUENT EPISODES OF CRAMPS AND MUSCLE WEAKNESS. THIS WAS UPDATED ON JUL 19, 2017.
Remedial action
- Recall