IBALANCE, PATELLA IMP DOME 40 X 10MM
Received Aug 25, 2021 · Event occurred Aug 4, 2021
Report 1220246-2021-03560 · MDR key 12364345
Device
Generic name
Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Manufacturer
Arthrex, Inc.Model number
IBALANCE, PATELLA IMP DOME 40 X 10MMCatalog number
AR-504-PSE0
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT HAD AN ADVERSE REACTION SEVERAL YEARS AFTER IMPLANTATION. ADDITIONAL INFORMATION REQUESTED.