LOGIC TIBIA PS MOD INSRT SZ 4 15MM
Report
- Report Number
- 1038671-2022-00894
- Event Type
- Injury
- Date Received
- August 5, 2022
- Date of Event
- August 1, 2016
- Report Date
- July 1, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- UDI-DI
- 10885862001917
- PMA / PMN Number
- K033883
- Removal / Correction Number
- Z-0021-2022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CONCOMITANT MEDICAL PRODUCTS: 02-010-01-0240 - LOGIC FEMORAL PS CEM LEFT SZ 4 - 3870561. 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE - 3874746. 200-02-35 - THREE PEG PATELLA 35MM - 3882599. 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T - 3894761. NO DEVICE RETURN ANTICIPATED. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
H6: 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 SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION.
ADDITIONAL INFORMATION: B5. CORRECTED INFORMATION: H6: HEALTH EFFECT-CLINICAL CODE.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, E, G. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, INFECTION OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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.
IT WAS REPORTED VIA A LEGAL FILING THAT A MALE PATIENT, WHO WAS INITIALLY IMPLANTED ON (B)(6) 2015 ON HIS LEFT KNEE WITH AN OPTETRAK TKA SYSTEM, INDICATED THE TKA SYSTEM HAD FAILED IN (B)(6) 2016 AND UNDERWENT REVISION SURGERY APPROXIMATELY 1 YEAR 3 MONTHS POST THE INITIAL IMPLANT PROCEDURE. THEY REMOVED THE IMPLANT AND REPLACED IT WITH ANOTHER JOINT REPLACEMENT SYSTEM.
REVISION OPERATIVE NOTES WERE PROVIDED. INDICATIONS: 1. INFECTED LEFT TOTAL KNEE ARTHROPLASTY. 2. RETAINED HARDWARE (SCREW LEFT FEMORAL DISTAL SHAFT). PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: N/A. OPERATION: 1. RESECTION OF LEFT TOTAL KNEE ARTHROPLASTY, WITH PLACEMENT OF ANTIBIOTIC-IMPREGNATED SPACER. 2. REMOVAL OF HARDWARE, DEEP, LEFT DISTAL FEMUR. DESCRIPTION OF OPERATION: THERE WAS GROSS PURULENCE IN THE KNEE AND SIGNIFICANT SYNOVITIS. MULTIPLE CULTURES WERE SENT. THE POLYETHYLENE WAS DISSOCIATED AND THE COMPONENTS WERE REMOVED IN THE USUAL FASHION WITHOUT ANY SIGNIFICANT ASSOCIATED BONE LOSS. CEMENT WAS REMOVED WITH A HIGH-SPEED BUR. THE PREVIOUS SCREW WAS LOCATED AND REMOVED. ADDITIONAL ETHIBOND ALONG THE TRACK OF AN OLD ACL RECONSTRUCTION WAS ALSO CAREFULLY REMOVED WITH A BUR. I ALSO REMOVED THE OLD ACL GRAFT REMNANTS FROM THE ANTERIOR TIBIA. CHECKED EVERYTHING FLUOROSCOPICALLY; IT LOOKED CLEAN. IRRIGATED IT THOROUGHLY WITH SALINE CLORPACTIN AND PLAIN SALINE. THE PATIENT WAS REVISED TO A COMPETITOR¿S ANTIBIOTIC SPACER. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM WITHOUT COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2433099 | LOGIC TIBIA PS MOD INSRT SZ 4 15MM | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED | JWH | EXACTECH, INC. | LOGIC TIBIA PS MOD INSRT SZ 4 15MM | UNK | 10885862001917 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |