FDA Adverse Event
Injury
Summary report: N
VANGUARD COMPLETE KNEE SYSTEM - BEARING
MDR report key: 6411780
·
Received March 16, 2017
Report
- Report Number
- 0001825034-2017-01697
- Event Type
- Injury
- Date Received
- March 16, 2017
- Report Date
- March 19, 2017
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- JWH
- PMA / PMN Number
- PK113550
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCOMITANT MEDICAL PRODUCTS: 183113, ANGUARD PS INTERLOK FEM - RT 72.5, LOT 291330; 141235, BIOMET CC CRUCIATE TRAY 79MM, LOT J28427007; 184788, SERIES A PAT THIN 37X8.6 3 PEG , LOT 955790. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
UPON RECEIPT OF ADDITIONAL INFORMATION, THIS REPORT WILL BE COMPLETED UNDER MANUFACTURING REPORT NUMBER 0001825034-2017-01707.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PATIENT IS BEING REVISED FOR INSTABILITY WITH A BEARING EXCHANGE SCHEDULED TO TAKE PLACE ON AN UNKNOWN DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193936 | VANGUARD COMPLETE KNEE SYSTEM - BEARING | PROSTHESIS, KNEE | JWH | BIOMET ORTHOPEDICS | 295250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |