BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 22541818 · Received July 18, 2025

    Report

    Report Number
    3005180920-2025-00629
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    July 2, 2025
    Report Date
    July 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030810909
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03-07-2025. CUP: MPACT 01.32.158MH ACETABULAR SHELL Ø58 MULTI-HOLE LOT. 2349362: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-07-2024 EXPIRATION DATE: 2029-07-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW (INFECTION AND MOBILIZATION CONSIDERED). ADDITIONAL COMPONENTS INVOLVED IN THE EVENT. LINER: MPACT 01.32.3648HCT MPACT FLAT LINER HC 36/F (K103721) LOT. 2406864: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-05-2024 EXPIRATION DATE: 2029-04-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0015 CANCELLOUS BONE SCREW Ø 6,5 L 15 (K200391) LOT 2315733: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-08-2023 EXPIRATION DATE: 2028-07-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0020 CANCELLOUS BONE SCREW Ø 6,5 L 20 (K200391) LOT. 2312887: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-07-2023 EXPIRATION DATE: 2028-06-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0030 CANCELLOUS BONE SCREW Ø 6,5 L 30 200391) LOT. 2307613: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-07-2023 EXPIRATION DATE: 2028-07-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0020 CANCELLOUS BONE SCREW Ø 6,5 L 20 (K200391) LOT. 2319062: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-09-2023 EXPIRATION DATE: 2028-08-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0025 CANCELLOUS BONE SCREW Ø 6,5 L25(K200391) LOT. 2413325: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-07-2024 EXPIRATION DATE: 2029-06-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0035 CANCELLOUS BONE SCREW Ø 6,5 L35 (K200391) LOT. 2312906: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-07-2023 EXPIRATION DATE: 2028-06-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S (K132879) LOT. 2434502: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-07-2023 EXPIRATION DATE: 2028-06-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. INFECTION AND SEPTIC MOBILIZATION ARE A KNOWN POSSIBLE COMPLICATION OF PRIMARY HIP ARTHROPLASTY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    IN (B)(6) 2025 THE PATIENT UNDERWENT THA. ON THE (B)(6), THE PATIENT UNDERWENT REVISION SURGERY DUE TO AN ACETABULAR FRACTURE CAUSED BY TRAUMA. NO MDR SENT AS IT WAS A TRAUMATIC EVENT. CURRENTLY, ON THE (B)(6), THE PATIENT UNDERWENT REVISION DUE TO SUSPECTED INFECTION. THE SURGEON REMOVED THE HEAD AND LINER AND PERFORMED A WASHOUT. ALSO, THE SURGEON TESTED THE CUP STABILITY AND FOUND IT MOBILIZED. THE SURGEON THEN PROCEEDED WITH THE REVISION OF THE CUP TOO WITH A 62 MPACT TWO-HOLES CUP. SURGERY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400176 MPACT ACETABULAR SYSTEM ACETABULAR SHELL Ø58 MULTI-HOLE LZO MEDACTA INTERNATIONAL SA 01.32.158MH 2349362 07630030810909

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention