FDA Adverse Event
Injury
Summary report: N
UNKNOWN NATURAL KNEE II TIBIAL COMPONENT
MDR report key: 3150127
·
Received May 30, 2013
Report
- Report Number
- 1822565-2013-00884
- Event Type
- Injury
- Date Received
- May 30, 2013
- Report Date
- May 1, 2013
- Manufacturer
- ZIMMER, INC.
- Product Code
- MBH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO OSTEOLYSIS AND WEAR OF THE ARTICULAR SURFACE. EXACT IMPLANT AND EXPLANT DATES ARE UNKNOWN. THE DEVICES ARE REPORTED TO HAVE BEEN IN-VIVO APPROXIMATELY 9 YEARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 237683 | UNKNOWN NATURAL KNEE II TIBIAL COMPONENT | KNEE PROSTHESIS | MBH | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention | UNKNOWN NATURAL KNEE II ARTICULAR SURFACE:| CATALOG #UNK, LOT #UNK |