FDA Adverse Event
Injury
Summary report: N
HIP PROSTHESIS SCREW
MDR report key: 5060782
·
Received September 8, 2015
Report
- Report Number
- 1020279-2015-00645
- Event Type
- Injury
- Date Received
- September 8, 2015
- Date of Event
- July 19, 2015
- Report Date
- July 19, 2015
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS.
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE A COMPRESSION SCREW THAT HAD BACKED OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 592088 | HIP PROSTHESIS SCREW | JDH | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |