FDA Adverse Event
Injury
Summary report: N
PROSTHESIS, ELBOW
MDR report key: 3222208
·
Received July 12, 2013
Report
- Report Number
- 0001825034-2013-02649
- Event Type
- Injury
- Date Received
- July 12, 2013
- Date of Event
- June 14, 2013
- Report Date
- June 14, 2013
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- JDC
- PMA / PMN Number
- PUNK
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT UNDERWENT AN ELBOW PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO INFECTION. THE HEAD AND STEM WERE REMOVED AND REPLACED WITH UNKNOWN PRODUCT. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322170 | PROSTHESIS, ELBOW | JDC | BIOMET ORTHOPEDICS | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |