POLISHED FINNED TIB TRAY 67MM
Received May 21, 2018 · Event occurred Nov 17, 2017
Report 0009610576-2018-00018 · MDR key 7528845
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet Spain, S.l.Model number
N/ACatalog number
141252
Lot number
2017050502
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
59 YR
- Hematoma
- Hematoma
Narrative
Additional Manufacturer Narrative
(B)(4). (B)(6). CONCOMITANT PRODUCTS: VANGUARD CR TIB BRG 63/67 X 10MM REF.183420;LOT.572570; VANGUARD CR ILOK FEM-RT 60 REF.183004;LOT.J3943450; SERIES A PAT STD 31 3 PEG REF.184764;LOT.928210. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K945028. PRODUCT REMAINS IMPLANTED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2017. SUBSEQUENTLY, ON (B)(6) 2017, IT WAS REPORTED THAT THE PATIENT UNDERWENT KNEE WASHOUT WITH AN EVACUATION OF HEMATOMA OF SKIN OF LIMB PLUS WOUND EXPLORATION.