BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX OPTION Ø 32

    MDR report key: 9738114 · Received February 21, 2020

    Report

    Report Number
    3005180920-2020-00078
    Event Type
    Injury
    Date Received
    February 21, 2020
    Date of Event
    January 22, 2020
    Report Date
    February 21, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809330
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 JANUARY 2020: LOT 1905667: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-09-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 29 JANUARY 2020: LINER: MPACT 01.32.3239HCT FLAT PE HC LINER 32/C (K103721) LOT 1900216: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APR-2019. EXPIRATION DATE: 2024-03-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CUP: MPACT 01.32.148DH ACETABULAR SHELL 48 TWO-HOLES (K132879) LOT 1902267: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2019. EXPIRATION DATE: 2024-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. STEM: QUADRA-H 01.12.21SN CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK (K082792) LOT 188789: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2019. EXPIRATION DATE: 2024-01-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. SCREWS: MPACT 01.32.6520 CANCELLOUS BONE SCREW, FLAT HEAD 6,5 L 20 (K103721) LOT 1905812: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-AUG-2019. EXPIRATION DATE: 2024-07-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. SCREWS: MPACT 01.32.6525 CANCELLOUS BONE SCREW, FLAT HEAD 6,5 L 25 (K103721) LOT 1905813: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-AUG-2019. EXPIRATION DATE: 2024-07-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. ON (B)(6) 2020, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT. IT WAS OBSERVED THAT THE PATIENT HAD SUPERFICIAL WOUND DRAINAGE. THE SURGEON PERFORMED AN I&D AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201626 BALL HEADS: MECTACER BIOLOX OPTION Ø 32 HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.231H 1905667 07630030809330

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention