FDA Adverse Event
Summary report: N
GII STANDARD TIBIA B
MDR report key: 3232166
·
Received July 17, 2013
Report
- Report Number
- 1020279-2013-00366
- Date Received
- July 17, 2013
- Date of Event
- July 1, 2013
- Report Date
- July 1, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REVISION SURGEON PERFORMING A TKA MADE NECESSARY BONE PREPS AND TRIALING. AFTERWARDS, THE REQUESTED IMPLANTS WERE BROUGHT IN FROM THE SALES REP AND PRESENTED TO THE SURGEON. THE SURGEON AND STAFF AGREED THAT THE SIZES WERE CORRECT. THE IMPLANTS WERE IMPLANTED INTO THE PATIENT. DURING POST-OPERATIVE DICTATION, IT WAS NOTED THAT THE WRONG SIDE IMPLANTS WERE USED. THE SURGEON IMMEDIATELY SET UP A REVISION SURGERY THE SAME DAY TO EXCHANGE THE IMPLANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330784 | GII STANDARD TIBIA B | GNS II CMT TIB SIZE 7 {} LEFT | JWH | SMITH & NEPHEW, INC. | 12MM03591 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | 71453231/ 13DM00754| 71421216 / 13BM16850 |