LOGIC KNEE COMPONENTS
Report
- Report Number
- 1038671-2024-00916
- Event Type
- Injury
- Date Received
- April 22, 2024
- Date of Event
- February 9, 2016
- Report Date
- August 28, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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 PATIENT¿S PAIN CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. D10: 208-06-02 - CC DISTAL FEM AUGMENT SZ 2, 10MM : 2408355 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T : 2833258 208-06-02 - CC DISTAL FEM AUGMENT SZ 2, 10MM : 3767642 201-78-25 - SMALL HEADED SHARP PIN, 1 1/8" 4 PACK : 3984775 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK : 4041223 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK : 4041232 200-02-35 - THREE PEG PATELLA 35MM : 4060056 02-012-50-2011 - LOGIC FIT/RBK AUGMENT 1/2 BLOCK SZ 2, 5MM : 4095575 02-012-50-2011 - LOGIC FIT/RBK AUGMENT 1/2 BLOCK SZ 2, 5MM : 4095577 02-012-60-1080 - LOGIC STEM EXT 10MM X 80MM : 4101013 02-010-06-0521 - LOGIC POST. AUG. BLOCK SIZE 2, 5MM : 4101169 02-010-06-0521 - LOGIC POST. AUG. BLOCK SIZE 2, 5MM : 4101178 02-012-60-1280 - LOGIC STEM EXT 12MM X 80MM : 4113006 02-010-06-0220 - LOGIC CC FEMORAL SIZE 2, LEFT : 4114526 203-96-21 - (11-2714) STRYKER 2000 90X13/21X 1.9MM : 54091 H7: Z-0021-2022
(D10) CONCOMITANT DEVICES: 02-010-06-0220 - LOGIC CC FEMORAL SIZE 2, LEFT : (B)(6). 02-012-65-2015 - LOGIC CC TIB INSERT SIZE 2, 15MM: (B)(6). 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T : (B)(6). 02-012-60-1080 - LOGIC STEM EXT 10MM X 80MM : (B)(6). 200-02-35 - THREE PEG PATELLA 35MM : (B)(6). 02-012-60-1280 - LOGIC STEM EXT 12MM X 80MM : (B)(6). 208-06-02 - CC DISTAL FEM AUGMENT SZ 2, 10MM : (B)(6). 02-010-06-0521 - LOGIC POST. AUG. BLOCK SIZE 2, 5MM : (B)(6). 208-06-02 - CC DISTAL FEM AUGMENT SZ 2, 10MM : (B)(6). 02-010-06-0521 - LOGIC POST. AUG. BLOCK SIZE 2, 5MM : (B)(6). 02-012-50-2011 - LOGIC FIT/RBK AUG 1/2 BLOCK SZ 2, 5MM : (B)(6). 02-012-50-2011 - LOGIC FIT/RBK AUG 1/2 BLOCK SZ 2, 5MM : (B)(6). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B5, D1, D4 - REMOVE ALL, D7B - REMOVE, D10 , H6 - CLINICAL, IMPACT, DEVICE PROBLEM, AND COMPONENT CODES. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
REVISION AND DATE ADDED - SEE: (B5). (D6B).
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D4. EXPLANT DATE IS UNKNOWN. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D4, G4, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, D, E, F. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REPORTED REVISION DUE TO ARTHROFIBROSIS CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO PATIENT FACTORS/ETIOLOGY, COMPONENT POSITIONING, ARTHROFIBROSIS, INFECTION AND/OR IMPLANT SELECTION. THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, 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.
IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 48 YO FEMALE PATIENT EXPERIENCED ARTHROFIBROSIS/PERSISTENT STIFFNESS IN THE LEFT KNEE. THE PATIENT HAD DIFFICULTY GETTING PAST 45 DEGREES OF FLEXION 6 WEEKS POSTOP. THE DATE OF ADVERSE EVENT ONSET IS UNK-UNK-2016. THE PATIENT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA ON (B)(6) 2016. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING. THE CASE REPORT INFORMATION WAS NOT PROVIDED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED ARTHROFIBROSIS/PERSISTENT STIFFNESS AND HAD DIFFICULTY GETTING PAST 45 DEGREES OF FLEXION; 6 WEEKS POST-OP. AS A RESULT, APPROXIMATELY 1 MONTH AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.
IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 48 YO FEMALE PATIENT EXPERIENCED ARTHROFIBROSIS/PERSISTENT STIFFNESS IN THE LEFT KNEE. THE PATIENT HAD DIFFICULTY GETTING PAST 45 DEGREES OF FLEXION 6 WEEKS POSTOP. THE DATE OF ADVERSE EVENT ONSET IS UNK-UNK-2016. THE PATIENT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA ON (B)(6) 2016. ON (B)(6)2024, THE PATIENT UNDERWENT A REVISION SURGERY AND THE OUTCOME IS NOW CONSIDERED RESOLVED. THE CASE REPORT INDICATES THIS EVENT IS POSSIBLY TO THE DEVICE AND/OR TO THE PROCEDURE. 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 PATIENT¿S PAIN CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2242567 | LOGIC KNEE COMPONENTS | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL | JWH | EXACTECH, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |