FDA Adverse Event
Injury
Summary report: N
LOGIC CC TIB INSERT SIZE 5, 11MM
MDR report key: 15885756
·
Received November 30, 2022
Report
- Report Number
- 1038671-2022-01535
- Event Type
- Injury
- Date Received
- November 30, 2022
- Date of Event
- September 24, 2021
- Report Date
- October 29, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- UDI-DI
- 10885862266231
- PMA / PMN Number
- K150890
- Removal / Correction Number
- Z-0021-2022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCTS: 4145264, 02-010-06-0250 - LOGIC CC FEMORAL SIZE 5, LEFT, 4952893, 02-012-45-5040 - LGC TIBIAL FIT TRAY CEM SZ 5F / 4T, 4354559, 02-012-60-1425 - LOGIC STEM EXT 14MM X 25MM AND 5027344, 200-02-35 - THREE PEG PATELLA 35MM.
Additional Manufacturer Narrative · 0
SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, REASON NOT REPORTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS PATIENT WAS REVISED. REASON WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2607160 | LOGIC CC TIB INSERT SIZE 5, 11MM | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL | JWH | EXACTECH, INC. | 02-012-65-5011 | UNK | 10885862266231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| R |