FDA Adverse Event
Injury
Summary report: N
ACUMATCH M-SERIES NECK SEGMENT, LPB¿, HIGH OFFSET
MDR report key: 6739493
·
Received July 25, 2017
Report
- Report Number
- 1038671-2017-00502
- Event Type
- Injury
- Date Received
- July 25, 2017
- Date of Event
- July 20, 2017
- Report Date
- September 7, 2018
- Manufacturer
- EXACTECH, INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
PENDING EVALUATION.
Additional Manufacturer Narrative · 1
ENGINEERING EVALUATION NOTED THAT THE REVISION REPORTED WAS LIKELY THE RESULT OF FRACTURE OF THE NECK SEGMENT AT THE DISTAL TAPER. THIS FAILURE LIKELY OCCURRED BY FATIGUE CRACK PROPAGATION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE COMPONENTS WERE NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
REVISION OF HIP COMPONENTS - REASON UNKNOWN.
Description of Event or Problem · 1
REVISION OF HIP COMPONENTS - REASON UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522204 | ACUMATCH M-SERIES NECK SEGMENT, LPB¿, HIGH OFFSET | NECK SEGMENT | LPH | EXACTECH, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |