BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MS-30, STEM, STANDARD, CEMENTED, 10, TAPER 12/14

    MDR report key: 19937422 · Received August 8, 2024

    Report

    Report Number
    0009613350-2024-00331
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    July 16, 2024
    Report Date
    November 22, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    K040803
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). D6A: THE IMPLANTATION OCCURRED SOMETIME IN 1998. D10: WEBER MEDULLARY PLUG SIZE 3 ITEM#3223 LOT #: B349630. PROTEK DISTAL CENTRALIZER 10MM ITEM#300110 LOT #: A943667. ALLOFIT SHELL/POLAR SCREWPLUG 58/LL ITEM#4248 LOT #: B075163. METASUL HEAD 28/0MM 'M'' 12/14 ITEM#192806 LOT #: B525451. METASUL INSERT LL/28 ITEM#4348LOT #: B339117. G2: FOREIGN: AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. NO PRODUCTS WERE RETURNED TO THE POST MARKET SURVEILLANCE TEAM FOR EXAMINATION. HOWEVER, FOUR IMAGES WERE PROVIDED. TWO OF THE FOUR IMAGES SHOW THE IMPLANT LABELS OF THE EXPLANTED PRODUCTS AND NEWLY IMPLANTED PRODUCTS DURING THE REVISION SURGERY. ONE IMAGE SHOWS THE EXPLANTED AND DISASSEMBLED METASUL HEAD IN THE OPERATING THEATER, WHERE PART OF THE TAPER CONNECTION CAN BE SEEN. NOTHING CONSPICUOUS CAN BE IDENTIFIED BASED ON THIS PROVIDED IMAGE. THE FINAL IMAGE RECEIVED SHOWS THE EXPLANTED MS30 STEM COVERED IN SOME BIOLOGICAL DEBRIS IN THE OPERATING THEATER. ONLY SEVERAL AREAS OF WHAT APPEARS TO BE CEMENT RESIDUE APPEARS TO BE ADHERING TO THE POLISHED SURFACE OF THE STEM. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. NO SURGICAL NOTES WERE PROVIDED. HOWEVER, ONE RADIOGRAPHS WAS PROVIDED AND REVIEWED BY A RADIOLOGIST WITH THE FOLLOWING ASSESSMENT: SINGLE AP VIEW RIGHT HIP DEMONSTRATES A RIGHT TOTAL HIP ARTHROPLASTY WITH MILD RADIOLUCENCY ALONG THE BONE CEMENT INTERFACE OF THE FEMORAL STEM. ADDITIONAL NOTE IS MADE OF CORTICAL THICKENING OF THE PROXIMAL FEMORAL DIAPHYSIS AT THE DISTAL FEMORAL STEM. NO BONY FRACTURE SEEN. MILD HETEROTOPIC OSSIFICATION ABOUT THE RIGHT HIP. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY DUE TO LOOSENING, APPROXIMATELY 26 YEARS AFTER INITIAL IMPLANTATION. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210027 MS-30, STEM, STANDARD, CEMENTED, 10, TAPER 12/14 HIP PROTHESIS LZO ZIMMER GMBH N/A B268601

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention| H SEE H11 NARRATIVE.