UNK
Received May 14, 2026 · Event occurred Jun 13, 2025
Report 1220246-2026-02840 · MDR key 25171764
Device
Generic name
Tot Anat Shouldr Prosth, Uncem
Manufacturer
Arthrex, Inc.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Patient Device Interaction Problem
Patient
NA · Unknown
- Unspecified Infection
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 24-APR-2026, A CLINDEX NOTIFICATION WAS RECEIVED VIA EMAIL INDICATING THAT ADDITIONAL INFORMATION HAD BEEN OBTAINED FROM A CLINICAL STUDY (SHOULDER ARTHROPLASTY REGISTRY, AIRR 00608). THE SUBJECT PREVIOUSLY UNDERWENT TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2025 UTILIZING THE ECLIPSE IMPLANT SYSTEM. REVIEW OF CLINICAL RECORDS IDENTIFIED THAT THE PATIENT PRESENTED ON (B)(6) 2025 FOR EVALUATION OF A SURGICAL INCISION, WHICH APPEARED INFECTED; CULTURES OBTAINED AT THAT TIME DEMONSTRATED MODERATE GROWTH OF SERRATIA MARCESCENS. AN INCISION AND DRAINAGE PROCEDURE WAS PERFORMED ON (B)(6) 2025. THE PATIENT CONTINUED ROUTINE FOLLOW-UP WITHOUT COMPLICATION UNTIL ON (B)(6) 2025, WHEN THEY REPORTED PAIN AND DELAYED RECOVERY. A REVISION PROCEDURE FROM ANATOMIC SHOULDER ARTHROPLASTY TO REVERSE SHOULDER ARTHROPLASTY WAS PERFORMED ON (B)(6) 2025, DURING WHICH A SECONDARY DRAINAGE WAS COMPLETED; THE REVISION PROCEDURE WAS SUCCESSFUL. STUDY PARTICIPATION CONCLUDED ON (B)(6) 2025. DEVICE CAUSALITY WAS ASSESSED AS PROBABLY RELATED.