LOGIC
Report
- Report Number
- 1038671-2022-01103
- Event Type
- Injury
- Date Received
- September 13, 2022
- Date of Event
- August 8, 2022
- Report Date
- October 22, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- UDI-DI
- 10885862001856
- PMA / PMN Number
- K093360
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
NO DEVICE RETURN ANTICIPATED DUE TO CLINICAL STUDY POLICY. CONCOMITANTS: 02-010-01-0235 LOGIC FEMORAL PS CEM LEFT SZ 3.5, 02-012-45-3535 LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T, 200-02-38 THREE PEG PATELLA 38MM, FEMORAL STEM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; REASON WAS NOT REPORTED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT'S UNDERLYING MULTIPLE JOINT CONDITIONS.
IT WAS REPORTED VIA A CLINICAL STUDY, EXACTECH KNEE REPLACEMENT STUDY, THAT A 71 YO MALE, H: 172 CM, WHO WAS INITIALLY IMPLANTED ON THE LEFT KNEE ON (B)(6) 2016 FOR THE PRIMARY INDICATION OF OSTEOARTHRITIS, UNDERWENT A SINGLE STAGE REVISION ON (B)(6) 2022 APPROXIMATELY 6 YEARS 1 MONTH POST THE INITIAL IMPLANT PROCEDURE. STUDY INDICATES THE OUTCOME AS RESOLVED ON (B)(6) 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2391886 | LOGIC | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, | JWH | EXACTECH, INC. | LOGIC TIBIA PS MOD INSRT SZ 3.5 11MM | UNK | 10885862001856 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention | SEE H10. |