FDA Adverse Event
Injury
Summary report: N
UNK SHOULDER GLENOID GLOBAL APG+
MDR report key: 12760198
·
Received November 7, 2021
Report
- Report Number
- 1818910-2021-24502
- Event Type
- Injury
- Date Received
- November 7, 2021
- Date of Event
- October 21, 2021
- Report Date
- October 21, 2021
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- HSD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 0
PATIENT WAS REVISED DUE TO INSTABILITY. CONVERTED FROM TOTAL TO REVERSE. NOTHING FURTHER TO REPORT. DOI: UNKNOWN. DOR: (B)(6) 2021. RIGHT SHOULDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1655382 | UNK SHOULDER GLENOID GLOBAL APG+ | SHOULDER GLENOID | HSD | DEPUY ORTHOPAEDICS INC US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | APG GLENOID| HUMERAL HEAD| SIZE 12 GLOBAL ANATOMIC PROX BODY |