LOGIC TIBIA PS MOD INSRT SZ 2 9MM
Report
- Report Number
- 1038671-2024-03152
- Event Type
- Injury
- Date Received
- August 28, 2024
- Date of Event
- August 21, 2024
- Report Date
- July 16, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- UDI-DI
- 10885862001726
- PMA / PMN Number
- K033883
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D10: CONCOMITANT DEVICES: N/A 02-012-41-2020 - LOGIC TIBIA TRAPTRAY CEM SZ 2F/2T. N/A 02-010-01-0320 - LOGIC FEMORAL PS CEM RIGHT SZ 2. N/A 200-02-32 - THREE PEG PATELLA 32MM. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
B3: CORRECTED. H6: CORRECTED HEALTH EFFECT AND INVESTIGATION CLINICAL CODES.
IT WAS REPORTED THAT APPROXIMATELY 89 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1520988 | LOGIC TIBIA PS MOD INSRT SZ 2 9MM | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL | JWH | EXACTECH, INC. | 10885862001726 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | SEE H11 |