BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC PATELLA COMPONENT

    MDR report key: 21539959 · Received March 6, 2025

    Report

    Report Number
    1038671-2025-01465
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    April 2, 2024
    Report Date
    May 4, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B5, D1, H6, H11 THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. IT WAS DISCOVERED THAT A BAG USED IN THE PACKAGING OF OUR POLYETHYLENE INSERTS HAD BEEN PRODUCED OUTSIDE OF OUR QUALITY SPECIFICATIONS. THE USE OF THESE NON-CONFORMING BAGS MAY ENABLE INCREASED OXYGEN DIFFUSION TO THE UHMWPE (ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE) INSERT, RESULTING IN INCREASED OXIDATION OF THE MATERIAL RELATIVE TO INSERTS PACKAGED WITH BAGS THAT CONFORM TO SPECIFICATIONS. FOR INSERTS WITH GREATER THAN FIVE YEARS OF SHELF LIFE, INCREASED OXIDATION OF THE INSERTS CAN LEAD TO PREMATURE POLYETHYLENE WEAR RESULTING IN REVISION SURGERY. THE NON-CONFORMING BAGS WERE ALSO USED IN THE PACKAGING OF OUR PATELLA COMPONENTS. AN ADDITIONAL HHE AND CRC WERE HELD TO ASSESS THE RISK OF THE NON-CONFORMING PACKAGING SPECIFICALLY RELATED TO PATELLA COMPONENTS. PATELLA COMPONENTS PACKAGED IN NON-EVOH VACUUM BAGS, WHICH HAVE A MAXIMUM 5-YEAR SHELF-LIFE PRIOR TO EXPIRATION, HAVE REDUCED RISK OF OXIDATIVE DEGRADATION. SINCE MANUFACTURING INFORMATION WAS NOT AVAILABLE FOR THE PATELLA COMPONENT, IT COULD NOT BE CONFIRMED WHETHER THE DEVICE WAS PACKAGED IN A NON-CONFORMING VACUUM BAG. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED OVER TEN YEARS PRIOR TO THE REPORTED EVENT. BASED ON THE AGE OF THE PATIENT¿S DEVICES AND THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE OR INFORMATION TO SUGGEST THAT THE REPORTED LOOSENING IS MANUFACTURING-RELATED. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, MAY HAVE RESULTED FROM PROSTHESIS WEAR, INSTABILITY, PATELLAR LOOSENING, AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED OVER TEN YEARS PRIOR TO THE REPORTED EVENT. POTENTIAL CONTRIBUTIONS OF USERS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 141 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE FOR PAIN, ASEPTIC LOOSENING OF THE PATELLA COMPONENT, AND MARKED OSTEOLYSIS FROM POLYETHYLENE WEAR. NO ADDITIONAL INFORMATION IS AVAILABLE. SERIAL: (B)(6). ITEM NUMBER AND FULL DESCRIPTION: 02-012-35-3011 - LOGIC TIBIA PS MOD INSRT SZ 3 11MM 510(K): K033883. PRODUCT CODE: JWH. RECALL NUMBER: Z-0021-2022. CONCOMITANT DEVICES COULD NOT BE DETERMINED FROM PROVIDED INFORMATION.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 11 YEARS AND 10 MONTHS POST THE INITIAL TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED. THE PATELLA WAS SUBLUXATED LATERALLY. THERE WAS VERY EXTENSIVE SYNOVITIS AND A VERY THOROUGH SYNOVECTOMY OF THE JOINT WAS PERFORMED. THE POLYETHYLENE LINER WAS REMOVED. THERE WAS NOTED TO BE WEAR OF THE LINER. NEXT, THE FEMORAL COMPONENT WAS REMOVED. THERE WAS SIGNIFICANT FIBROUS TISSUE BENEATH IT WITH OSTEOLYSIS, ESPECIALLY ANTERIORLY. THERE WAS NO EVIDENCE OF INFECTION GROSSLY ALTHOUGH MULTIPLE SPECIMENS WERE SENT TO PATHOLOGY. ATTENTION WAS THEN DIRECTED TO THE FEMUR. A LAMINA SPREADER WAS INSERTED LATERALLY AND THE MEDIAL POSTERIOR SYNOVITIS AND SCAR TISSUE AS WELL AS ANY POSTERIOR OSTEOPHYTES WERE THEN REMOVED. THE LAMINA SPREADER WAS SWITCHED TO THE MEDIAL SIDE AND THEN THE LATERAL POSTERIOR SYNOVITIS AND SCAR TISSUE AS WELL AS POSTERIOR OSTEOPHYTES WERE REMOVED. THE REMAINING INTRACONDYLAR NOTCH TISSUE WAS REMOVED WITH ELECTROCAUTERY. ATTENTION WAS THEN TURNED TO THE PATELLA. THE PATELLA WAS NOTED TO BE LOOSE AND THERE WAS SOME WEAR ON THE PATELLA. A FREEHAND PATELLAR CUT WAS MADE WITHOUT DIFFICULTY AND THE OLD PATELLA COMPONENT WAS REMOVED. THERE WAS SOME OSTEOLYSIS OF THE REMAINING PATELLA THAT WAS DEBRIDED. THE POSTERIOR CAPSULE WAS CAUTERIZED TO MINIMIZE POSTOPERATIVE BLEEDING. A PERIARTICULAR PAIN INJECTION WAS INJECTED INTO THE POSTERIOR CAPSULE MEDIALLY AND PERIARTICULAR TISSUES. BONE ENDS WERE IRRIGATED AND DRIED. BONE GRAFTING OF SMALL FEMORAL AND TIBIAL CYSTS AS WELL AS THE INTRAMEDULLARY CANAL WAS PERFORMED. THE KNEE WAS COPIOUSLY IRRIGATED, SUCTIONED AND DRIED THOROUGHLY TO PREPARE FOR CEMENTATION. THE PATIENT WAS CLOSED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. BECAUSE THE PATIENT HAS FILED A LEGAL CLAIM, IT APPEARS THAT THEY ARE ALLEGING PROSTHESIS WEAR OF AN EXACTECH POLYETHYLENE DEVICE. PER THE AVAILABLE INFORMATION, IT ALSO APPEARS THAT THE PATIENT IS ALLEGING INSTABILITY, PATELLAR LOOSENING, AND FEMORAL KNEE DEBONDING/LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508436 OPTETRAK LOGIC PATELLA COMPONENT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1