FDA Adverse Event
Injury
Summary report: N
EXACTECH, INC.
MDR report key: 10677470
·
Received October 14, 2020
Report
- Report Number
- 1038671-2020-00574
- Event Type
- Injury
- Date Received
- October 14, 2020
- Date of Event
- September 26, 2020
- Report Date
- December 18, 2020
- Manufacturer
- EXACTECH, INC.
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
SECTION H10: (H3) THE EVALUATION NOTED THAT THE EVENT WAS MOST LIKELY THE RESULT OF ASEPTIC LOOSENING BETWEEN THE FEMORAL COMPONENT AND THE BONE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND ADDITIONAL INFORMATION WAS NOT PROVIDED.
Additional Manufacturer Narrative · 1
PENDING EVALUATION.
Description of Event or Problem · 1
AS REPORTED, APPROXIMATELY 2.5 YEARS AFTER THA, THIS PATIENT HAD A LEFT STEM LOOSENED OVER TIME AND WAS REVISED. THE CUP NEEDED TO BE REMOVED AND THE AHS LINER WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1143163 | EXACTECH, INC. | HIP COMPONENTS | JDI | EXACTECH, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |