FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 864438
·
Received June 13, 2007
Report
- Report Number
- 1020279-2007-00138
- Event Type
- Injury
- Date Received
- June 13, 2007
- Date of Event
- March 26, 2007
- Report Date
- May 15, 2007
- Manufacturer
- SMITH & NEPHEW, INC., ORTHOPAEDIC DIV
- Product Code
- JDD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BHR | FEMORAL CUP | JDD | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Hospitalization| R |