FDA Adverse Event
Injury
Summary report: N
TNBN POL COCR I-BEAM TRAY 67
MDR report key: 8105305
·
Received November 27, 2018
Report
- Report Number
- 0009610576-2018-00039
- Event Type
- Injury
- Date Received
- November 27, 2018
- Report Date
- November 27, 2018
- Manufacturer
- BIOMET SPAIN, S.L.
- Product Code
- KRR
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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
PATIENT IS SUSPECTED ALLERGIC REACTION TO THE MATERIAL IN THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 946472 | TNBN POL COCR I-BEAM TRAY 67 | PROSTHESIS, KNEE | KRR | BIOMET SPAIN, S.L. | N/A | 2017110881 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization |