FDA Adverse Event
Injury
Summary report: N
LOGIC CR TIB INSERT SLOPE++, SZ 2, 11MM
MDR report key: 15526199
·
Received October 2, 2022
Report
- Report Number
- 1038671-2022-01215
- Event Type
- Injury
- Date Received
- October 2, 2022
- Date of Event
- May 1, 2022
- Report Date
- October 14, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- UDI-DI
- 10885862174321
- PMA / PMN Number
- K111400
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 02-010-03-0320 - LOGIC CR FEMORAL CEM, RIGHT, SZ 2 4139525, 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T 3718586, 200-02-29 - THREE PEG PATELLA 29MM 4155989, 203-96-42 - 11-4132 STRYKER SYS 6 90X13/21X1.19 43332, H7: Z-0021-2022.
Additional Manufacturer Narrative · 0
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 POLY SWAP/REVISION HAS BEEN REPORTED TO BE DUE TO THE DEVICE RECALL; NO OTHER REASON REPORTED.
Description of Event or Problem · 0
AS REPORTED, THE PATIENT HAD AN INITIAL TKA ON (B)(6) 2015. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO THE RECALL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2315986 | LOGIC CR TIB INSERT SLOPE++, SZ 2, 11MM | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED | JWH | EXACTECH, INC. | LOGIC CR TIB INSERT SLOPE++, SZ 2, 11MM | 10885862174321 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention | SEE H10 |