FDA Adverse Event
Injury
Summary report: N
COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING / STANDARD 44MM
MDR report key: 2212218
·
Received August 15, 2011
Report
- Report Number
- 1825034-2011-00709
- Event Type
- Injury
- Date Received
- August 15, 2011
- Date of Event
- August 23, 2010
- Report Date
- July 18, 2011
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- KWS
- PMA / PMN Number
- K080642
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT FILED (B)(4), 2011.
Description of Event or Problem · 1
IT WAS DISCOVERED UPON INTERNAL REVIEW OF INVOICE RECORDS THAT THE HUMERAL BEARING SIZE DID NOT MATCH THE GLENOID SIZE THAT WAS IMPLANTED DURING THIS SHOULDER ARTHROPLASTY PROCEDURE THAT OCCURRED ON (B)(6), 2010. NO REPORT OF REVISION PROCEDURE HAS BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING / STANDARD 44MM | PROSTHESIS, SHOULDER | KWS | BIOMET ORTHOPEDICS | N/A | 949130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |