FDA Adverse Event
Injury
Summary report: N
UNKNOWN KNEE
MDR report key: 3870642
·
Received June 12, 2014
Report
- Report Number
- 0001825034-2014-05353
- Event Type
- Injury
- Date Received
- June 12, 2014
- Report Date
- May 28, 2014
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- JWH
- PMA / PMN Number
- PUNKNOWN
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. PMA/510 NUMBER. MANUFACTURE DATE ¿ UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT IRRIGATION ON AN UNKNOWN DATE, INDICATIVE OF AN INFECTION. HOWEVER, THERE HAS BEEN NO REPORTED REVISION TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348269 | UNKNOWN KNEE | PROSTHESIS, KNEE | JWH | BIOMET ORTHOPEDICS | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |