FDA Adverse Event
Injury
Summary report: N
MG II TOTAL KNEE SYSTEM TIBIAL ARTICULAR SURFACE ANTERIOR CO
MDR report key: 395043
·
Received May 17, 2002
Report
- Report Number
- 1822565-2002-00048
- Event Type
- Injury
- Date Received
- May 17, 2002
- Date of Event
- September 14, 2001
- Report Date
- April 22, 2002
- Manufacturer
- ZIMMER, INC.
- Product Code
- HRY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT IS REPORTED THAT IN 2000 PT UNDERWENT LEFT TOTAL KNEE REPLACEMENT. FOLLOWING, ON 8/2001, WHILE GETTING OUF OF A CAR, PT TWISTED THEIR KNEE. THE NEXT MONTH, X-RAYS CONFIRMED THAT THE TIBIAL ARTICULATING SURFACE HAD DISLOCATED FROM THE TIBIAL PLATE. AS A RESULT, 4 DAYS LATER, THE KNEE WAS REVISED WHERE THE TIBIAL ARTICULATING SURFACE WAS INDEED FOUND TO BE DISPLACED. THE TIBIAL PLATE AND ARTICULATING SURFACE WERE BOTH REMOVED AND REPLACED USING MG II PRODUCTS. PT DID VERY WELL POST-OP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MG II TOTAL KNEE SYSTEM TIBIAL ARTICULAR SURFACE ANTERIOR CO | KNEE PROSTHESIS | HRY | ZIMMER, INC. | * | 41263800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| R |