FDA Adverse Event
Malfunction
Summary report: N
GCK UNI TIB TRAY CEM SZ2 RM/LL
MDR report key: 1034942
·
Received April 24, 2008
Report
- Report Number
- 1818910-2008-01160
- Event Type
- Malfunction
- Date Received
- April 24, 2008
- Date of Event
- March 26, 2008
- Report Date
- March 26, 2008
- Manufacturer
- DEPUY-RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS INC
- Product Code
- HRY
- PMA / PMN Number
- K070267
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
DURING SURGERY, IT WAS DISCOVERED THAT THE TIBIAL TRAY THAT WAS IN A BOX LABELED AS A SIZE 2 WAS ACTUALLY A SIZE 3. DESPITE THE SITUATION, THE SURGEON WAS PLEASED WITH THE OUTCOME OF THE PROCEDURE FOR THE PT. THE SURGERY WAS DELAYED APPROX 30 - 40 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GCK UNI TIB TRAY CEM SZ2 RM/LL | 87HRY | HRY | DEPUY-RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS INC | NA | B55BK4000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |