UNK
Received Jul 9, 2026 · Event occurred Apr 6, 2026
Report 1220246-2026-03684 · MDR key 25769221
Device
Generic name
Prosthesis, Shoulder, Cemented
Manufacturer
Arthrex, Inc.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Loss of Range of Motion
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem
ON 12-JUN-2026, AN AE NOTIFICATION (AIRR-00608) WAS RECEIVED VIA EMAIL INDICATING INFORMATION FROM THE SHOULDER ARTHROPLASTY REGISTRY (B)(6). THE REPORT STATED THAT THE SUBJECT UNDERWENT PRIMARY SHOULDER ARTHROPLASTY ON (B)(6) 2025 UTILIZING AN ECLIPSE IMPLANT SYSTEM WITH LESSER TUBEROSITY OSTEOTOMY APPROACH. ROTATOR CUFF STRUCTURES WERE REPORTED AS INTACT AT THE TIME OF IMPLANTATION. APPROXIMATELY 9 MONTHS POSTOPERATIVELY (ONSET DATE (B)(6) 2026), THE SUBJECT EXPERIENCED PERSISTENT POSTOPERATIVE STIFFNESS WITH LIMITED RANGE OF MOTION DESPITE UNDERGOING PHYSICAL THERAPY. THE ADVERSE EVENT WAS CLASSIFIED AS POST-OPERATIVE STIFFNESS. THE EVENT WAS ASSESSED AS MODERATE IN SEVERITY, NOT RELATED TO TRAUMA, AND DEVICE CAUSALITY WAS ASSESSED AS UNRELATED. DUE TO UNRESOLVED SYMPTOMS, THE SUBJECT UNDERWENT SURGICAL INTERVENTION CONSISTING OF ARTHROSCOPIC CAPSULAR RELEASE AND DEBRIDEMENT, WITH A PLANNED PROCEDURE DATE OF (B)(6) 2026. NO DEVICE MALFUNCTION OR BREAKAGE WAS REPORTED. THE OUTCOME AT THE TIME OF REPORTING WAS ONGOING AND UNCHANGED.