FDA Adverse Event
Injury
Summary report: N
ZIMMER ARTICULAR SURFACE WITH HINGE POST
MDR report key: 2153190
·
Received June 23, 2011
Report
- Report Number
- 1822565-2011-01498
- Event Type
- Injury
- Date Received
- June 23, 2011
- Report Date
- May 27, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- KRO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- 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 WAS REPORTED THAT A PLANNED REVISION OF THE PT'S SEGMENTAL KNEE WAS PENDING DUE TO PAIN. THE REVISION WAS PERFORMED ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER ARTICULAR SURFACE WITH HINGE POST | KRO | ZIMMER, INC. | 61194563 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention | ZIMMER SEGMENTAL SYSTEM FEMORAL HINGE SVC KIT:| MALE/FEMALE TAPER: CATALOG #00585004604| ZIMMER SEGMENTAL SYSTEM SEGMENT WITH| CATALOG #00585001395, LOT #61308335| ZIMMER SEGMENTAL SYSTEM POLYETHYLENE INSERT:| CATALOG #00585001302, LOT #61185230| ZIMMER SEGMENTAL SYSTEM DISTAL FEMORAL COMPONENT:| CATALOG #00585007013, LOT #60964328 |