FDA Adverse Event
Injury
Summary report: N
R3 PRIMARY LINERS XL CONST 66-70MM
MDR report key: 3932238
·
Received July 14, 2014
Report
- Report Number
- 1020279-2014-00413
- Event Type
- Injury
- Date Received
- July 14, 2014
- Date of Event
- May 22, 2014
- Report Date
- November 19, 2014
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Additional Manufacturer Narrative · 1
LOT NUMBER CORRECTED - PRODUCTS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410396 | R3 PRIMARY LINERS XL CONST 66-70MM | HIP IMPLANT | JDH | SMITH & NEPHEW, INC. | 10CM00631R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 71338742/11AM11216 |