BIOMET CC I-BEAM TRAY
Received Feb 18, 2020 · Event occurred Jun 4, 2019
Report 0001825034-2020-00739 · MDR key 9719740
Device
Generic name
Prosthesis, Knee
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
141226
Lot number
J6475328
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
45 YR
- Adhesion(s)
- Pain
- Swelling
- Limited Mobility Of The Implanted Joint
- Adhesion(s)
- Pain
- Swelling
- Limited Mobility Of The Implanted Joint
Narrative
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR ILOK FEM-RT 70 CATALOG # 183012 LOT # J6452368, VNGD ANT STBLZD BRG 14X83 CATALOG # 189124 LOT # 748850. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2020-00735. 0001825034-2020-00738. REMAINS IMPLANTED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT HAD A TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED KNEE STIFFNESS, PAIN SWELLING, AND ARTHROFIBROSIS THAT RESULTED IN A MANIPULATION UNDER ANESTHESIA. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.
Description of Event or Problem
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. IT IS NOW VERIFIED THAT THIS DEVICE IS RELATED TO THE EVENT.
Additional Manufacturer Narrative
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED. IT IS NOW VERIFIED THAT THIS DEVICE IS RELATED TO THE EVENT.