TRULIANT TIB IMP PS INSERT SZ 5 12MM
Report
- Report Number
- 1038671-2022-01134
- Event Type
- Injury
- Date Received
- September 16, 2022
- Date of Event
- October 18, 2024
- Report Date
- April 22, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- UDI-DI
- 10885862304643
- PMA / PMN Number
- K171045
- Removal / Correction Number
- Z-0023-2022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEVICE RETURN NOT ANTICIPATED AT THIS TIME AS IT REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCTS: 02-020-11-0250, 5131454 - TRULIANT PS CEM FEM PS CEM LEFT SZ 5; 02-022-45-5050, 5428300 - TRULIANT TIB FIT TRAY CEM SZ 5F / 5T; 200-02-41, 5243033 - THREE PEG PATELLA 41MM; 201-78-18, 5261857 - HOLDING PIN HEADLESS NO RIBS W/30 DEG PT 4 PACK. 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 PAIN AND SUBSEQUENT PLANNED REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.
H6. INVESTIGATION RESULTS FOR PROSTHESIS WEAR - THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF FEMORAL LOOSENING, OSTEOLYSIS, AND PROSTHESIS WEAR AS STATED IN THE PROVIDED INFORMATION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE(S),IMAGES OF THE DEVICE/ PRE-REVISION RADIOGRAPHS, AND OPERATIVE NOTES WERE NOT AVAILABLE FOR EVALUATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. CORRECTION H7 & H9 - THIS DEVICE IS NOT PART OF A RECALL.
ADDITIONAL INFORMATION: A2, B1, B5, B7, H6: HEALTH EFFECT - CLINICAL CODE. CORRECTED INFORMATION: B3, H6: HEALTH EFFECT - IMPACT CODE, MEDICAL DEVICE PROBLEM CODE.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED IN CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND FEMORAL LOOSENING 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 THAT A MALE PATIENT, WHO WAS INITIALLY IMPLANTED ON THE LEFT KNEE ON (B)(6) 2018, WAS SEEN IN THE CLINIC AND THEY ARE HAVING SYMPTOMS/PAIN/EFFUSIONS, INDICATING A REVISION SURGERY IS NECESSARY. A REVISION LTKA HAS BEEN SCHEDULED FOR (B)(6) 2022. NO OTHER PATIENT INFORMATION REPORTED.
NO ADDITIONAL INFORMATION.
PRE-OP/POST-OP DIAGNOSES: FAILED LEFT TKA SECONDARY TO ASEPTIC FEMORAL LOOSENING. INDICATIONS: INCREASING EFFUSIONS AND WEIGHTBEARING PAIN WITH CLINICAL EVIDENCE OF A FEMORAL LOOSENING. PROCEDURE: THE PATELLA WAS WELL FIXED, LEFT IN PLACE. PREVIOUS 12 MM INSERT WAS REMOVED. THE FEMORAL WAS DISIMPACTED FROM INTACT CEMENT MANTLE. TIBIA WAS WELL FIXED, LEFT IN PLACE. PREVIOUS 12MM INSERT WAS REMOVED. THE FEMORAL WAS DISIMPACTED. TIBIA WAS WELL FIXED AND LEFT IN PLACE. THE PATIENT WAS REVISED TO EXACTECH DEVICES. NO COMPLICATIONS. PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1875298 | TRULIANT TIB IMP PS INSERT SZ 5 12MM | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL | JWH | EXACTECH, INC. | TRULIANT TIB IMP PS INSERT SZ 5 12MM | UNK | 10885862304643 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male | Required Intervention | SEE H10. |