FDA Adverse Event
Injury
Summary report: N
REFLECTION
MDR report key: 2233343
·
Received September 2, 2011
Report
- Report Number
- 1020279-2011-00348
- Event Type
- Injury
- Date Received
- September 2, 2011
- Date of Event
- July 27, 2011
- Report Date
- September 2, 2011
- Manufacturer
- SMITH & NEPHEW, INC
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A PROBABLE CAUSE FOR THE (B)(4) METAL TRANSFER IS DISLOCATION. THE FERROUS METAL TRANSFER MOST LIKELY OCCURRED WHEN THE LINER CAME INTO CONTACT WITH A SURGICAL INSTRUMENT UPON REMOVAL. THE ACETABULAR COMPONENT SHOWED SIGNS OF BONE ONGROWTH. NO MANUFACTURING DEVIATIONS WERE FOUND IN THIS INVESTIGATION.
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 | REFLECTION | FEMORAL COMPONENT | JDH | SMITH & NEPHEW, INC | 09AM15948 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | (B)(4), LOT 09CM13625: (B)(4), LOT: 09AM19487 |