UNIVERS APEX HUMERAL STEM, SIZE 5
Report
- Report Number
- 1220246-2025-04122
- Event Type
- Injury
- Date Received
- September 24, 2025
- Date of Event
- July 22, 2025
- Report Date
- November 11, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- KWS
- PMA / PMN Number
- K153115
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 501
Narratives
ADDITIONAL INFORMATION: B5, D1, D2A, D2B, D4, G3, G4.
ADDITIONAL INFORMATION: D6A, D6B, G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS A PATIENT-SPECIFIC EVENT AS THE PATIENT UNDERWENT A REVISION SURGERY.
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION WAS RECEIVED ON 9/25/2025: IT WAS CONFIRMED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DURING WHICH AN AR-9100-05S ARTHREX UNIVERS HUMERAL STEM, AR-9106-01 ARTHREX UNIVERS VAULTLOCK GLENOID, AND AR-9145-15 ARTHREX UNIVERS HUMERAL HEAD WERE REMOVED. THE SURGERY WAS COMPLETED USING NEW ARTHREX IMPLANTS.
ON 9/9/2025, A CLINDEX NOTIFICATION WAS RECEIVED REGARDING A PATIENT LISTED IN THE SHOULDER ARTHROPLASTY REGISTRY. THE PATIENT HAD RETURNED TO THE CLINIC ON (B)(6) 2025 DUE TO PAIN AND FUNCTIONAL LIMITATIONS. A CT SCAN WAS ORDERED AND REVIEWED. BASED ON IMAGING AND CLINICAL EXAMINATION, A ROTATOR CUFF TEAR WAS DIAGNOSED. THE RECOMMENDED TREATMENT WAS REVISION TO REVERSE SHOULDER ARTHROPLASTY, AND SURGERY WAS SCHEDULED FOR ON (B)(6) 2025. THIS EVENT WAS DETERMINED TO BE UNRELATED TO THE UNIVERS REVERS APEX IMPLANT PLACED ON (B)(6) 2017. ADDITIONAL INFORMATION RECEIVED ON 9/17/2025: DURING THE INITIAL SHOULDER ARTHROPLASTY, THE FOLLOWING IMPLANTS WERE USED: AR-9100-05S ARTHREX UNIVERS HUMERAL STEM, AR-9106-01 ARTHREX UNIVERS VAULTLOCK GLENOID, AND AR-9145-15 ARTHREX UNIVERS HUMERAL HEAD. POSTOPERATIVELY, THE PATIENT EXPERIENCED SYMPTOMS THAT WERE INITIALLY MANAGED WITH CONSERVATIVE MEASURES, INCLUDING PHYSICAL THERAPY AND NSAID USE AS NEEDED. WHEN SYMPTOMS PERSISTED DESPITE THESE INTERVENTIONS, A CT SCAN WAS PERFORMED, REVEALING SUPRASPINATUS ATROPHY AND A ROTATOR CUFF TEAR. BASED ON THESE FINDINGS, IT WAS DETERMINED THAT REVISION FROM TOTAL SHOULDER ARTHROPLASTY TO REVERSE SHOULDER ARTHROPLASTY WOULD BE THE MOST APPROPRIATE TREATMENT. THE RSA REVISION PROCEDURE WAS COMPLETED ON (B)(6) 2025. IT WAS NOT CONFIRMED IF ANY PRODUCTS WERE EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2384334 | UNIVERS APEX HUMERAL STEM, SIZE 5 | PROSTHESIS, SHOULDER, CEMENTED | KWS | ARTHREX, INC. | UNIVERS APEX HUMERAL STEM, SIZE 5 | 10036030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |