BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RM

    MDR report key: 18864974 · Received March 8, 2024

    Report

    Report Number
    3005180920-2024-00100
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    October 16, 2023
    Report Date
    June 5, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895623
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07-MAR-2024. LOT 2106609: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUL-2021. EXPIRATION DATE: 2026-07-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 07-MAR-2024: MOTO PARTIAL KNEE 02.15.005R PATELLO FEMORAL JOINT S5 R (K200122) LOT 2203778: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2022. EXPIRATION DATE: 2027-05-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. MOTO PARTIAL KNEE 02.15.E038 MOTO E-CROSS PATELLA D38 (K213071) LOT 2110551: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-DEC-2021. EXPIRATION DATE: 2026-12-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. MOTO PARTIAL KNEE 02.18.TF5.RM TIBIAL TRAY FIX CEMENTED S5 RM (K162084) LOT 2105882: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-AUG-2021. EXPIRATION DATE: 2026-07-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. MOTO PARTIAL KNEE 02.18.IF5.09.RM TIBIAL INSERT FIX S5 RM - 9MM (K162084) LOT 2106134: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2021. EXPIRATION DATE: 2026-07-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT. ABOUT 8 MONTHS AFTER PARTIAL KNEE REPLACEMENT (MEDIAL UNICOMPARTMENTAL + PATELLO-FEMORAL), THE PATIENT IS IN PAIN AND AN ARTHROSCOPY REVEALS THAT THE LATERAL CONDYLE HAS GONE THROUGH AN AVASCULAR NECROSIS DEGENERATIVE PROCESS. FOR THIS REASON, DISEASE PROGRESSION, CONVERSION TO A TOTAL KNEE IS REQUIRED AND THE FORMERLY IMPLANTED DEVICES NEED TO BE RETRIEVED, EVEN THOUGH STILL WORKING PROPERLY.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT PRIMARY SURGERY ON (B)(6) 2023. DURING AN ARTHROSCOPY SURGERY PERFORMED BECAUSE THE PATIENT FELT PAIN, IT WAS NOTICED AVASCULAR NECROSIS OF THE NON-PROSTHETIC LATERAL FEMUR. NO ISSUE WAS DETECTED ON THE IMPLANTS. NO INFECTION AND NO ALLERGY. AS FAR AS WE KNOW, THE PATIENT HAS NO BONE PATHOLOGY. ON (B)(6) 2023, THE PATIENT HAS BEEN SUCCESSFULLY REVISED TO A GMK-SPHERE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2162976 MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RM PARTIAL KNEE FEMORAL COMPONENT HSX MEDACTA INTERNATIONAL SA 2106609 07630030895623

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention