ORTHOPEDIC SALVAGE SYSTEM (OSS)
Received May 12, 2026
Report 0001825034-2026-01254 · MDR key 25147463
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Loss of Range of Motion
Narrative
Description of Event or Problem
IT WAS REPORTED PATIENT HAS BEEN INDICATED FOR REVISION DUE TO DECREASED RANGE OF MOTION. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Additional Manufacturer Narrative
(B)(4). D10: PN: CP114836 LN: 891830 RS SIDE EXP DSTL FMRL LT 20CM. PN: 161035 LN: UNKNOWN OSS RS AXLE. PN: 178524 LN: UNKNOWN CPS TRANSVERSE PIN 6PK 20MM. PN: 178525 LN: 891830 CPS TRANSVERSE PIN 6PK 24MM. D4: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT IS STILL IMPLANTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.