BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIM-LOCK BIOLOX DELTA CERAMIC LINER

    MDR report key: 21078139 · Received January 6, 2025

    Report

    Report Number
    3010536692-2025-00001
    Event Type
    Injury
    Date Received
    January 6, 2025
    Date of Event
    December 11, 2024
    Report Date
    December 9, 2025
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    THE ALLEGED COMPLAINT IS CONFIRMED. VISUAL REVIEW OF A PROVIDED IMAGE OF THE IMPLANT, (B)(4) LOT 1850072, REVEALS THAT THE INSTRUMENT HAS BROKEN INTO SEVERAL PIECES. THIS INSTRUMENT WAS NOT RETURNED FOR INVESTIGATION, BUT A PICTURE OF THE BROKEN IMPLANT WAS PROVIDED. THIS IMPLANT LOT WAS MANUFACTURED IN 2020. REVIEW OF THE DESIGN HISTORY RECORD (DHR) FOR THE SUBJECT MANUFACTURING LOT INDICATES THAT THIS IMPLANT WAS MANUFACTURED TO SPECIFICATION. THERE IS NO TREND FOR THIS IMPLANT AND FAILURE WITH THIS BEING THE FIRST COMPLAINT RECEIVED FOR THIS LOT. A SALES ORDER HISTORY REVIEW REVEALS THAT MANY OTHER IMPLANTS FROM THIS LOT HAVE BEEN IMPLANTED WITH NO COMPLAINTS. BASED ON A COMPLAINT REVIEW, IMPROPER SEATING TECHNIQUE OR PRESENCE OF DEBRIS ARE KNOWN CONTRIBUTING FACTORS TO THIS ISSUE. THE SURGICAL TECHNIQUE DESCRIBES THE INTENDED SEATING TECHNIQUE: "CLEAN OUT ANY SOFT TISSUE FROM THE INNER TAPER AREA BEFORE IMPACTING AND ENGAGING THE IMPLANT AND LINER. INSERT THE LINER BY HAND, ENSURING THAT THE FACE OF THE LINER IS PARALLEL WITH THE FACE OF THE SHELL. ENSURE THE LINER IS FLUSH WITH THE SHELL? ASSEMBLE THE MODULAR IMPACTOR TIP TO THE INSERT IMPACTOR HANDLE. ATTACH THE APPROPRIATE HEAD TRIAL THAT CORRESPONDS TO THE LINER DIAMETER AND PLACE INTO THE LINER. APPLY A SERIES OF MALLET BLOWS TO FULLY SEAT THE LINER." ADDITIONALLY, MICROPORT'S HIP SYSTEMS PACKAGE INSERT (150803-9) STATES, "FRACTURE OF CERAMIC COMPONENTS IS A SERIOUS COMPLICATION. SPECIAL CARE MUST BE TAKEN WITH CERAMIC DEVICES, WHICH MUST NOT BE USED IF DROPPED, EVEN IN THE ABSENCE OF ANY APPARENT DAMAGE. ONLY USE A PLASTIC TIP TO INTRODUCE THE CERAMIC DEVICES. IMPACT ACCORDING TO THE RECOMMENDED SURGICAL TECHNIQUE." HOWEVER, IT CANNOT BE DEFINITIVELY CONCLUDED WHAT CAUSED THE LINER TO FRACTURE.

    Description of Event or Problem · 0

    ALLEGEDLY, DURING A THA WITH ANTERIORPATH TECHNIQUE WHILE THE SURGEON WAS POSITIONING THE LINER BROKE INTO PIECES AT THE FIRST HIT. THE EQUIP TOOK 20 MINUTES TO CLEAN UP. THE SURGEON THEN IMPLANTED A POLY LINER. LIST OF MPO PRODUCTS USED: PRODUCT ID: PPPSQ048 PROCOTYL® P PS SHELL 3-HOLES /LOT NO.: 2015638 /QTY: 1. PRODUCT ID: PPRCLS02 PROFEMUR® PRESERVE CLASSIC /LOT NO.: 1934415 /QTY: 1. PRODUCT ID: PHA04410 FEMORAL HEAD BIOLOX DELTA /LOT NO.: 1883466 /QTY: 1. PRODUCT ID: PPEC0L32 PROCOTYL® P LPD E-CLASS® LINER /LOT NO.: 2014530 /QTY: 1.

    Description of Event or Problem · 0

    ALLEGEDLY, DURING A THA WITH ANTERIORPATH TECHNIQUE WHILE THE SURGEON WAS POSITIONING THE LINER BROKE INTO PIECES AT THE FIRST HIT. THE EQUIP TOOK 20 MINUTES TO CLEAN UP. THE SURGEON THEN IMPLANTED A POLY LINER. LIST OF MPO PRODUCTS USED: PRODUCT ID: PPPSQ048 PROCOTYL® P PS SHELL 3-HOLES /LOT NO.: 2015638 /QTY: (B)(4). PRODUCT ID: PPRCLS02 PROFEMUR® PRESERVE CLASSIC /LOT NO.: 1934415 /QTY: (B)(4). PRODUCT ID: PHA04410 FEMORAL HEAD BIOLOX DELTA /LOT NO.: 1883466 /QTY: (B)(4). PRODUCT ID: PPEC0L32 PROCOTYL® P LPD E-CLASS® LINER /LOT NO.: 2014530 /QTY: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351261 RIM-LOCK BIOLOX DELTA CERAMIC LINER HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. PHA04506 1850072

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention