LOGIC CC FEMORAL SIZE 4, RIGHT
Report
- Report Number
- 1038671-2023-00660
- Event Type
- Injury
- Date Received
- April 12, 2023
- Date of Event
- February 2, 2022
- Report Date
- January 7, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- UDI-DI
- 10885862265722
- PMA / PMN Number
- K150890
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
CONCOMITANTS MEDICAL PRODUCT(S): (B)(4) 02-010-06-0541 - LOGIC POST. AUG. BLOCK SIZE 4, 5MM; (B)(4) 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T; (B)(4) 02-012-60-1212 - LOGIC STEM EXT 12MM X 120MM; (B)(4) 02-012-60-1612 - LOGIC STEM EXT 16MM X 120MM; (B)(4) 02-012-61-6000 - LOGIC OFFSET STEM EXT COUPLER 6MM; (B)(4) 200-02-38 - THREE PEG PATELLA 38MM; (B)(4) 208-06-04 - CC DISTAL FEM AUGMENT SZ 4, 10MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
ASSOCIATED MFR # 1038671-2024-05006. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND FEMORAL LOOSENING. THE REPORTED PROSTHESIS WEAR AND FEMORAL LOOSENING COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
LEGAL CASE - (B)(6) (B)(4). RELATED CASE (B)(4) (B)(4). EMAIL FROM LEGAL: PER A REPORT FROM THE LEGAL DEPARTMENT, THE PATIENT HAD AN INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2013. THE PATIENT HAD TWO REVISIONS OF THE RIGHT KNEE (B)(6) 21 AND (B)(6) 22 ***ALL 3 OP REPORTS ARE ATTACHED. OP REPORT (B)(6) 2022. PRE & POST OP DIAGNOSIS: FAILED TOTAL RIGHT KNEE REPLACEMENT INDICATIONS: PATIENT HAD SEVERE PAIN DUE TO FAILED ASEPTIC LOOSENING OF TOTAL RIGHT KNEE REPLACEMENT. PT HAS FAILED CONSERVATIVE TREATMENT AND WISHED TO UNDERGO OPERATIVE INTERVENTION. RISKS, BENEFITS, AND ALTERNATIVES DISCUSSED WITH PATIENT. DESPITE POTENTIAL RISKS, THEY WISHED TO PROCEED WITH THE OPERATIVE INTERVENTION. INTRAOPERATIVE FINDINGS: LOOSE FEMORAL IMPLANT - REMOVED EASILY WITH MINIMAL BONE LOSS BUT CONCERNED FOR BONE QUALITY DISTAL FEMUR. I ELECTED TO SUE FEMORAL CONE. TIBIAL IMPLANT WAS VERY SOLID AND WELL FIXED - BACKSLAP DEVICE AND OSTEOTOMES WERE USED BUT STEM WOULD NOT BUDGE - CORTICAL WINDOW DISTAL TO THE STEM ALLOWED ME TO HIT THE STEM TIP AND KNOCK IT OUT RETROGRADE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. 5974191 02-010-06-0340 - LOGIC CC FEMORAL SIZE 4, RIGHT. PMA-510K: K150890. CONCOMITANTS: (B)(4) 02-012-65-4013 - LOGIC CC TIB INSERT SIZE 4, 13MM; NOTE: THE SERIAL NUMBER (B)(4) IS NOT AFFECTED BY THE RECALL; (B)(4) 02-010-06-0541 - LOGIC POST. AUG. BLOCK SIZE 4, 5MM; (B)(4) 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T; (B)(4) 02-012-60-1212 - LOGIC STEM EXT 12MM X 120MM; (B)(4) 02-012-60-1612 - LOGIC STEM EXT 16MM X 120MM; (B)(4) 02-012-61-6000 - LOGIC OFFSET STEM EXT COUPLER 6MM; (B)(4) 200-02-38 - THREE PEG PATELLA 38MM; (B)(4) 208-06-04 - CC DISTAL FEM AUGMENT SZ 4, 10MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2242881 | LOGIC CC FEMORAL SIZE 4, RIGHT | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER | JWH | EXACTECH, INC. | LOGIC CC FEMORAL SIZE 4, RIGHT | UNK | 10885862265722 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Required Intervention | SEE H10 |