FDA Adverse Event
Injury
Summary report: N
TRULIANT TIB IMP PS INSERT SZ 5 11MM
MDR report key: 19079519
·
Received April 10, 2024
Report
- Report Number
- 1038671-2024-00780
- Event Type
- Injury
- Date Received
- April 10, 2024
- Date of Event
- February 27, 2024
- Report Date
- April 10, 2024
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- UDI-DI
- 10885862304636
- PMA / PMN Number
- K152170
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H3: PENDING INVESTIGATION. D10: 5258130 02-020-11-0350 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 5 5216691 02-022-45-5040 - TRULIANT TIB FIT TRAY CEM SZ 5F / 4T 5383825 200-02-35 - THREE PEG PATELLA 35MM. H7: Z-0023-2022.
Description of Event or Problem · 0
AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO POLY WEAR OVER TIME. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 417991 | TRULIANT TIB IMP PS INSERT SZ 5 11MM | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL | JWH | EXACTECH, INC. | 10885862304636 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Male | Required Intervention |