FDA Adverse Event
Injury
Summary report: N
EXACTECH, INC.
MDR report key: 10677162
·
Received October 14, 2020
Report
- Report Number
- 1038671-2020-00572
- Event Type
- Injury
- Date Received
- October 14, 2020
- Date of Event
- September 15, 2020
- Report Date
- December 22, 2020
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
THE EVALUATION NOTED THAT THE REVISION REPORTED BASED ON REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS IS A DEVICE RELATED PROBLEM AND NO ALLEGATION AGAINST THE DEVICE. IMPLANTATION OF A TOTAL JOINT COULD RESULT PAIN, INFECTION, LOOSENING OF TOTAL JOINT HARDWARE AND THE PATIENT SHOULD MONITOR THEIR ACTIVITY AND STRESSES TO THE OPERATED ANKLE. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS PATIENT¿S CONDITIONS.
Additional Manufacturer Narrative · 1
PENDING EVALUATION.
Description of Event or Problem · 1
AS REPORTED, THIS (B)(6) MALE PATIENT PRESENTED WITH AN INFECTION OF THE RIGHT KNEE. THE DATE OF INITIAL IMPLANT OF RIGHT KNEE IS UNKNOWN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT RETURN AS THEY WERE SENT TO HSS RETRIEVAL LAB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1143914 | EXACTECH, INC. | CC KNEE COMPONENTS | JWH | EXACTECH, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |