OPTIPAC 80 REFOB PLUS BONE CMT-3
Received Mar 17, 2026 · Event occurred Jan 28, 2025
Report 3006946279-2026-00013 · MDR key 24615858
Device
Generic name
Bone Cement
Manufacturer
Biomet France S.a.r.l.Catalog number
4722502117-3
Lot number
AX15BD1106
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
53 YR · Male
- Pain
- Loss of Range of Motion
- Ambulation or Postural Difficulties
- Joint Laxity
- Swelling/ Edema
- Insufficient Information
- Radiolucent Lines
- Crepitus
Narrative
Additional Manufacturer Narrative
(B)(4) D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00880304990197. D10: ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR STABILIZED (CPS) RIGHT 12 MM HEIGHT, 42522600712, 65546350. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E, 42532007102, LOT 65561390. STEM EXTENSION TAPERED CEMENTED 14MM DIAMETER +30MM LENGTH, 42557000114, LOT 65845249 . FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD RIGHT SIZE 7, 42500606202, LOT 65625058. G2: FOREIGN - EVENT OCCURRED IN SOUTH AFRICA. G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K171540. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ON AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO UNKNOWN COMPLICATIONS. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.