LOGIC KNEE COMPONENTS
Report
- Report Number
- 1038671-2024-03981
- Event Type
- Injury
- Date Received
- October 15, 2024
- Date of Event
- July 16, 2013
- Report Date
- October 15, 2024
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
D10: CONCOMITANT DEVICES: 2382678 201-78-11 - HOLDING PIN SMALL HEADED SHORT 4 PACK. 2596712 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T. 2625448 02-010-01-0325 - LOGIC FEMORAL PS CEM RIGHT SZ 2.5. 2680986 200-02-29 - THREE PEG PATELLA 29MM. AA6828 13A2101 - CEMEX SYSTEM FAST GENTA 70G. 2143056 02-012-35-2511 - LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM. 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.
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 116 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, KNEE PAIN, SWELLING, EXACTECH KNEE IMPLANT UNSTABLE, AND KNEE COMPONENT LOOSENING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32744 | LOGIC KNEE COMPONENTS | LOGIC KNEE | JWH | EXACTECH, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H | SEE H10. |