InjuryKRR
TNBN POL COCR I-BEAM TRAY 67
Received Nov 27, 2018
Report 0009610576-2018-00039 · MDR key 8105305
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet Spain, S.l.Model number
N/ACatalog number
141242TNBN
Lot number
2017110881
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
68 YR
- Edema
- Pain
- Edema
- Pain
Narrative
Additional Manufacturer Narrative
(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
PATIENT IS SUSPECTED ALLERGIC REACTION TO THE MATERIAL IN THE IMPLANT.