FDA Adverse Event
Injury
Summary report: N
R3 3 HOLE ACET SHELL
MDR report key: 4113624
·
Received September 24, 2014
Report
- Report Number
- 1020279-2014-00580
- Event Type
- Injury
- Date Received
- September 24, 2014
- Date of Event
- September 19, 2014
- Report Date
- September 19, 2014
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO PAINFUL HIP AND LIMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 595580 | R3 3 HOLE ACET SHELL | 54MM OD | JDH | SMITH & NEPHEW, INC. | 14FM07988 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization| R | 71369894 LOT 14EM21384| 71335754 LOT 14EM09578| 71336500 LOT 13LM18923 |