FDA Adverse Event
Injury
Summary report: N
TNBN POL COCR FIN TIB TRAY 71 RAY 71 MM
MDR report key: 8159750
·
Received December 13, 2018
Report
- Report Number
- 0009610576-2018-00040
- Event Type
- Injury
- Date Received
- December 13, 2018
- Report Date
- December 12, 2018
- Manufacturer
- BIOMET SPAIN, S.L.
- Product Code
- JWH
- PMA / PMN Number
- EXEMP
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K945028.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PATIENT HAS BEEN SUFFERING AN ALLERGIC REACTION FOR A LONG TIME. THE DOCTOR HAS REQUESTED IF THE IMPLANTED KNEE TEP CONTAINS NICKEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1002410 | TNBN POL COCR FIN TIB TRAY 71 RAY 71 MM | PROSTHESIS, KNEE | JWH | BIOMET SPAIN, S.L. | N/A | 2015011660 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |