FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN PYROCARBON HUMERAL HEAD
MDR report key: 22403609
·
Received July 4, 2025
Report
- Report Number
- 3000931034-2025-00360
- Event Type
- Malfunction
- Date Received
- July 4, 2025
- Date of Event
- June 5, 2025
- Report Date
- July 4, 2025
- Manufacturer
- TORNIER S.A.S.
- Product Code
- QKW
- PMA / PMN Number
- DEN220012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 0
THE PATIENT HAS PRIMARY OSTEOARTHRITIS OF THE RIGHT SHOULDER (CONCENTRIC A1 GLENOID). NO PRIOR INJECTIONS OR SURGERIES. THE PATIENT UNDERWENT PYROCARBON HEMIARTHROPLASTY OF THE RIGHT SHOULDER 7 MONTHS AGO (NO GLENOID REAMING) AND WAS TREATED IN A SLING FOR 3 WEEKS AND STARTED PHYSICAL THERAPY. SINCE REMOVING THE SLING AND STARTING ACTIVITIES, THE PATIENT HAS NOTED PROGRESSIVE SQUEAKING NOISES FROM THE SHOULDER WITH RANGE OF MOTION. WHILE THE PAIN HAS IMPROVED AND THE PATIENT IS BACK TO ACTIVITIES, MORE FREQUENT AND REGULAR OCCURRENCES OF THE SQUEAKING FROM THE RIGHT SHOULDER WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2763746 | UNKNOWN PYROCARBON HUMERAL HEAD | SHOULDER JOINT HUMERAL (HEMI-SHOULDER) CERAMIC HEAD/METALLIC STEM CEMENTED | QKW | TORNIER S.A.S. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male |