FDA Adverse Event
Other
Summary report: N
CONSENSUS PRIMARY KNEE SYSTEM
MDR report key: 301598
·
Received October 19, 2000
Report
- Report Number
- 2952369-2000-00002
- Event Type
- Other
- Date Received
- October 19, 2000
- Date of Event
- October 2, 2000
- Report Date
- October 19, 2000
- Manufacturer
- HAYES MEDICAL, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING SURGERY TO REPLACE THE KNEE JOINT, THE SURGEON IMPLANTED A LEFT TIBIAL BASEPLATE. IT WAS THEN DISCOVERED THAT THE DEVICE WAS ACTUALLY A RIGHT TIBIAL BASEPLATE. THIS CAUSED A DELAY OF APPROXIMATELY FIFTEEN (15) MINUTES AND SURGICAL INTERVENTION TO REMOVE THE BASEPLATE AND REPLACE WITH A CORRECT COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSENSUS PRIMARY KNEE SYSTEM | CCM STEMMED TIBIAL BASEPLATE, LEFT, SIZE 4 | JWH | HAYES MEDICAL, INC. | NA | 230558A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Other| R | FEMORAL COMPONENT, TIBIAL INSERT. |