IBAL UKA FEM CEMENTED SIZ 4,L-MEDIAL
Received Dec 16, 2019 · Event occurred Nov 11, 2019
Report 1220246-2019-01494 · MDR key 9473632
Device
Generic name
- Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Manufacturer
Arthrex, Inc.Model number
IBAL UKA FEM CEMENTED SIZ 4,L-MEDIALCatalog number
AR-501-UFLD
Lot number
10195016
Product problems
- Unstable
- Naturally Worn
Patient
Not reported
- Pain
- Pain
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. IT WAS REPORTED THE RISK MANAGER WILL NOT RELEASE THE DEVICE. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.
Description of Event or Problem
THE PATIENT HAD ORIGINAL SURGERY FOR A UNI KNEE REPLACEMENT ON (B)(6) 2018. SHE REPORTED PAIN AND INSTABILITY; XRAYS SHOWED THAT THE POLY HAD WORN DOWN. ARTHREX PARTS AR-521-TBA8, AR-501-UFLD AND AR-501-TTLA WERE REMOVED. A TOTAL KNEE REVISION WAS DONE ON (B)(6) 2019 WITH A COMPETITOR'S DEVICE. PATIENT FEMALE, 60S.