THREE PEG PATELLA 35MM
Report
- Report Number
- 1038671-2025-01646
- Event Type
- Injury
- Date Received
- March 24, 2025
- Date of Event
- January 30, 2024
- Report Date
- June 16, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- JWH
- UDI-DI
- 10885862039606
- PMA / PMN Number
- K932690
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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 FEMORAL LOOSENING, INSTABILITY, LOSS OF RANGE OF MOTION, SUBSIDENCE/MIGRATION, AND PROSTHESIS WEAR. 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.
D10: 4114526 - 02-010-06-0220 - TRU CC FEMORAL SIZE 2 LEFT 4101169 - 02-010-06-0521 - TRU POST. AUG. SIZE 2, 5MM 4101178 - 02-010-06-0521 - TRU POST. AUG. SIZE 2, 5MM 4119509 02-012-65-2015 - TRU CC TIB INSERT SIZE 2, 15MM 2833258 - 02-012-45-2020 - LGC TIBIAL FIT TRAY CEM SZ 2F / 2T 4095575 - 02-012-50-2011 - TRU TIB AUG 1/2 SIZE 2, 5MM 4095577 - 02-012-50-2011 - TRU TIB AUG 1/2 SIZE 2, 5MM 4101013 - 02-012-60-1080 - TRU STEM EXT 10MM X 80MM 4113006 - 02-012-60-1280 - TRU STEM EXT 12MM X 80MM 2408355 - 208-06-02 - CC DISTAL FEM AUGMENT SZ 2, 10MM 3767642 - 208-06-02 - CC DISTAL FEM AUGMENT SZ 2, 10MM 3984775 - 201-78-25 - SMALL HEADED SHARP PIN, 1 1/8" 4 PACK 54091 - 203-96-21 - (11-2714) SAW BLADE 90X13/21X 1.9MM 4041223 - 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK 4041232 - 521-78-31 - THREADED PIN SIZE 2.6 COLLARLESS 2PK THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL 1038671-04/18/2024-002-R; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-00360. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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 LEGAL DOCUMENTATION THAT APPROXIMATELY 97 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, FEMORAL COMPONENT LOOSENING, INCREASING PAIN, MARKED STIFFNESS AND DECREASED RANGE OF MOTION. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. FINDINGS INDICATED GROSS LOOSENING FEMORAL COMPONENT; MARKED ARTHROFIBROSIS WITHOUT EVIDENCE OF INFECTION; OSTEOPENIA WITH SIGNIFICANT PROXIMAL FEMORAL BONE THINNING; SUBSIDENCE OF THE PATELLAR COMPONENT WITH AGGRESSIVE BONE OVERGROWTH AND PATELLA BAJA. THE SURGEON PERFORMED A REVISION OF THE FEMORAL COMPONENT AND TIBIAL POLYETHYLENE. THE SURGEON NOTED THAT THE FEMORAL CONDYLE MEDIALLY CRACKED DURING IMPACTION OF THE REVISION FEMORAL COMPONENTS, WHICH WAS THEN STABILIZED WITH A PIN. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM WITHOUT DIFFICULTY. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1131851 | THREE PEG PATELLA 35MM | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL | JWH | EXACTECH, INC. | 10885862039606 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Required Intervention| H | SEE H11 |