BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 S

    MDR report key: 14543100 · Received May 30, 2022

    Report

    Report Number
    3010536692-2022-00206
    Event Type
    Injury
    Date Received
    May 30, 2022
    Date of Event
    April 13, 2022
    Report Date
    July 29, 2022
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    UDI-DI
    M684PHA044141
    PMA / PMN Number
    K130376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED

    Additional Manufacturer Narrative · 0

    SECTION B.5: ADDITIONAL INFORMATION IN DESCRIPTION / SECTION F.6: AWARENESS DATE UPDATE/ SECTION H.6: HEALTH CODE (4530) REMOVED.

    Description of Event or Problem · 0

    ALLEGEDLY, THE PATIENT HAS BEEN SUFFERING MODERATE PAIN, AND THE IMPLANTS WERE REVISED FOR METALLOSIS, ACCORDING TO THE SURGEON. THE MODULAR NECK TRUNNION (FITTING IN TO THE STEM POCKET) WAS NOTICEABLY "BLACKENED". ALL IMPLANTS WERE REMOVED, AND REPLACED WITH A THR CEMENT SPACER. UNFORTUNATELY IT WASN'T POSSIBLE TO REMOVE THE LINER FROM THE PROCOTYL L SHELL, SO I CANT PROVIDE THE LOT NUMBER FOR THE BIOLOX LINER. ADDITIONAL INFORMATION RECEIVED ON 05/13/2022 FROM NJR: NJR ADVISED THAT THE PATIENT WAS REVIEWED DUE TO INFECTION AND ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS. REVISION NJR NUMBER: (B)(4), SITE: R, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

    Description of Event or Problem · 0

    ALLEGEDLY, THE PATIENT HAS BEEN SUFFERING MODERATE PAIN, AND THE IMPLANTS WERE REVISED FOR METALLOSIS, ACCORDING TO THE SURGEON. THE MODULAR NECK TRUNION (FITTING IN TO THE STEM POCKET) WAS NOTICEABLY "BLACKENED". ALL IMPLANTS WERE REMOVED, AND REPLACED WITH A THR CEMENT SPACER. UNFORTUNATELY IT WASN'T POSSIBLE TO REMOVE THE LINER FROM THE PROCOTYL L SHELL, SO I CANT PROVIDE THE LOT NUMBER FOR THE BIOLOX LINER. ADDITIONAL INFORMATION RECEIVED ON 05/13/2022 FROM NJR: NJR ADVISED THAT THE PATIENT WAS REVIEWED DUE TO INFECTION AND ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS. REVISION NJR NUMBER: 4859891. SITE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660568 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 S HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. PHA04414 1743438 M684PHA044141

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention