FDA Adverse Event
Injury
Summary report: N
ACUMATCH L-SERIES FEMORAL STEM, CEMENTED
MDR report key: 3802833
·
Received May 5, 2014
Report
- Report Number
- 1038671-2014-00159
- Event Type
- Injury
- Date Received
- May 5, 2014
- Date of Event
- December 22, 2012
- Report Date
- May 5, 2014
- Manufacturer
- EXACTECH, INC.
- Product Code
- LWJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICES ARE PENDING EVALUATION.
Description of Event or Problem · 1
HIP REVISION PERFORMED DUE TO A FRACTURED FEMORAL STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 266152 | ACUMATCH L-SERIES FEMORAL STEM, CEMENTED | ACUMATCH L-SERIES | LWJ | EXACTECH, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |