FDA Adverse Event
Injury
Summary report: N
ACUMATCH DISTAL STEM CENTRALIZER
MDR report key: 4173175
·
Received September 19, 2014
Report
- Report Number
- 1038671-2014-00445
- Event Type
- Injury
- Date Received
- September 19, 2014
- Date of Event
- March 25, 2014
- Report Date
- September 16, 2014
- Manufacturer
- EXACTECH, INC.
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
REVISION OF HIP COMPONENTS DUE TO A FRACTURE OF THE CEMENTED STEM. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. THIS EVENT TOOK PLACE OUTSIDE THE UNITED STATES, IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 583339 | ACUMATCH DISTAL STEM CENTRALIZER | DISTAL STEM CENTRALIZER | KWY | EXACTECH, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |