FDA Adverse Event
Injury
Summary report: N
UNKNOWN KNEE
MDR report key: 3951138
·
Received July 22, 2014
Report
- Report Number
- 0001825034-2014-06382
- Event Type
- Injury
- Date Received
- July 22, 2014
- Report Date
- September 5, 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
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS BIOMET PRODUCT IS NOT BEING REVISED. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY ON AN UNKNOWN DATE. AN UPCOMING REVISION PROCEDURE HAS BEEN INDICATED. THE REASON FOR THE UPCOMING REVISION PROCEDURE IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 428417 | UNKNOWN KNEE | PROSTHESIS, KNEE | JWH | BIOMET ORTHOPEDICS | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |