BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 20974700 · Received December 19, 2024

    Report

    Report Number
    3005180920-2024-01055
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    November 19, 2024
    Report Date
    December 19, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26-11-2024. LOT 2408723: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-04-2024. EXPIRATION DATE: 2029-04-04. 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. ADDITIONAL IMPLANTS REVISED. BATCH REVIEW PERFORMED ON 26-11-2024 ON CUP: MPACT 01.32.156MH ACETABULAR SHELL Ø56 MULTI-HOLE (K132879) LOT. 2346414 LOT 2346414: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-05-2024. EXPIRATION DATE: 2029-04-21. 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. BATCH REVIEW PERFORMED ON 26-11-2024 ON LINER: MPACT 01.32.4048HC10A FACE CHANG 10° PE HC LINER Ø40/F (K183582) LOT. 2312756 LOT 2312756: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-07-2023. EXPIRATION DATE: 2028-07-10. 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. BATCH REVIEW PERFORMED ON 26-11-2024 ON OTHER: SCREWS 01.43.0020 CANCELLOUS BONE SCREW Ø 6,5 L 20 (K200391) LOT. 2407053 LOT 2407053: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-05-2024. EXPIRATION DATE: 2029-04-21. 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. BATCH REVIEW PERFORMED ON 26-11-2024 ON OTHER: SCREWS 01.43.0025 CANCELLOUS BONE SCREW Ø 6,5 L 25 (K200391) LOT. 2312896 LOT 2312896: (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. BATCH REVIEW PERFORMED ON 26-11-2024 ON OTHER: SCREWS 01.43.0025 CANCELLOUS BONE SCREW Ø 6,5 L 25 (K200391) LOT. 2404323 LOT 2404323: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-03-2024. EXPIRATION DATE: 2029-03-13. 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. BATCH REVIEW PERFORMED ON 26-11-2024 ON OTHER: SCREWS 01.43.0030 CANCELLOUS BONE SCREW Ø 6,5 L 30 (K200391) LOT. 2410305 LOT 2410305: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-05-2024. EXPIRATION DATE: 2029-05-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 26-11-2024 ON OTHER: SCREWS 01.43.0040 CANCELLOUS BONE SCREW Ø 6,5 L 40 (K200391) LOT. 2347824 LOT 2347824: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-03-2024. EXPIRATION DATE: 2029-02-13. 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 IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. 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

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR AND THE CAUSE OF THE FRACTURE WAS UNKNOWN. ON (B)(6) 2024, THE SURGEON REVISED THE MEDACTA STEM WITH A COMPETITOR STEM AND REVISED THE MEDACTA CUP, LINER AND HEAD WITH ANOTHER MEDACTA CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR'S PRODUCT AND REVISED THE MEDACTA HEAD WITH ANOTHER MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2098046 MECTACER BIOLOX DELTA FEMORAL BALL HEAD HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.214 2408723

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention