POLISHED FINNED TIB TRAY 71MM
Received Aug 14, 2018 · Event occurred Jul 9, 2013
Report 0009610576-2018-00029 · MDR key 7780182
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet Spain, S.l.Model number
N/ACatalog number
141253
Lot number
2011110282
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
(B)(4). COMBINATION OF REFERENCE AND LOT PROVIDED HAS NOT BEEN MANUFACTURED BY (B)(4)ACCORDING TO OUR ERP. 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. CONCOMITANT MEDICAL PRODUCT: ASSOCIATE PRODUCT (B)(4). MANUFACTURED DATE UNKNOWN DUE TO COMBINATION OF REFERENCE AND LOT PROVIDED IS INCORRECT. PRODUCT LOCATION UNKNOWN.
Description of Event or Problem
A SURGERY OCCURRED FOR INFECTION. THE PROSTHESIS WAS IMPLANTED ON (B)(6) 2006 FOR KNEE ARTHROSIS. THREE COMPONENTS HAVE BEEN EXPLANTED.