FDA Adverse Event
Injury
Summary report: N
REFLECTION
MDR report key: 2935932
·
Received January 30, 2013
Report
- Report Number
- 1020279-2013-00055
- Event Type
- Injury
- Date Received
- January 30, 2013
- Date of Event
- January 14, 2013
- Report Date
- January 14, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
VISUAL INSPECTION OF THE IMPLANTS SHOWED BONE ON-GROWTH ON THE POROUS SURFACE OF THE IMPLANT. SEPARATION BETWEEN THE LINER AND THE SHELL WAS NOTED. DAMAGE TO THE EDGE OF THE XLPE LINER WAS APPARENT; THIS IS LIKELY DUE TO THE MULTIPLE DISLOCATIONS MENTIONED IN THE COMPLAINT STATEMENT. BASED ON THE INFORMATION PROVIDED, THE CAUSE FOR THE MULTIPLE DISLOCATIONS WAS UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41089 | REFLECTION | FEMORAL COMPONENT | JDH | SMITH & NEPHEW, INC. | XH000403-3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |