BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HEAD

    MDR report key: 22340692 · Received June 26, 2025

    Report

    Report Number
    0001822565-2025-02169
    Event Type
    Injury
    Date Received
    June 26, 2025
    Date of Event
    March 6, 2025
    Report Date
    June 26, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D2: THE COMMON DEVICE NAME AND PRODUCT CODE WERE POPULATED WITH THE BEST MATCH BASED ON REVIEW OF SIMILAR DEVICES. D4: IT WAS REPORTED THAT NO ADDITIONAL INFORMATION WAS AVAILABLE PER THE HOSPITAL/CUSTOMER, THEREFORE, NO PRODUCT IDENTIFICATION IS AVAILABLE. D10: UNKNOWN LINER UNKNOWN G2: FOREIGN: AUSTRALIA G4: DEVICE INFORMATION HAS NOT BEEN PROVIDED TO IDENTIFY THE ASSOCIATED 510K. SUGGESTED COMPONENT CODE: MECHANICAL (G04) - HEAD NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CANNOT BE CONFIRMED. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. CITATION: THEWLIS, D., BAHL, J., CHAI, H.W., ET AL. (2025). REVISION HIP ARTHROPLASTY THROUGH A GLUTEAL-SPARING EXTENDED POSTERIOR APPROACH MAY BE ABLE TO ACHIEVE SIMILAR FUNCTIONAL OUTCOMES TO PRIMARY HIP ARTHROPLASTY. ARTHROPLASTY TODAY, 33 (101681), 1-9. HTTPS://DOI.ORG/10.1016/J.ARTD.2025.101681

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE JOURNAL ARTICLE THAT THE PURPOSE OF THE STUDY WAS TO INVESTIGATE THE POSTOPERATIVE FUNCTIONAL OUTCOMES OF 2 GROUPS OF PRIMARY AND REVISION THA, WHEN REVISION PROCEDURES WERE PERFORMED USING A GLUTEAL-SPARING EXTENDED POSTERIOR APPROACH. THE STUDY ENROLLED 51 PRIMARY TOTAL HIP PATIENTS AND 21 REVISION TOTAL HIP PATIENTS. ALL PRIMARY THAS WERE PERFORMED VIA POSTERIOR APPROACH USING A PRESS-FIT TRILOGY ACETABULAR COMPONENT AND A CEMENTED COLLARLESS TAPERED FEMORAL STEM. ALL REVISION THAS WERE PERFORMED VIA POSTERIOR APPROACH AS WELL. IF AN ACETABULAR REVISION WAS PERFORMED, A TRILOGY OR TM MODULAR / TMARS COMPONENT. IN THE CASE OF POOR BONE QUALITY OR CONTACT, 2-3 SCREWS WERE IMPLANTED AS WELL. IF A FEMORAL STEM REVISION WAS PERFORMED, A COLLARLESS POLISHED TAPERED STEM OR ZIMMER MODULAR REVISION STEM WAS USED. REVISION STEMS WERE CEMENTED THROUGH A CEMENT-WITHIN-CEMENT EXCHANGE, IMPACTION BONE GRAFTING, OR BY CEMENTING ALONG OF A LONG STEM. THE PRIMARY GROUP HAD A MEAN AGE OF 69.2 YEARS AT TIME OF SURGERY (RANGE 64.2-74.2), AND THE REVISION GROUP HAD A MEAN AGE OF 72.8 YEARS AT THE TIME OF SURGERY (RANGE 66.8-78.8). FOLLOW-UP WAS CONDUCTED AT 3 MONTHS AND 1 YEAR POSTOPERATIVELY. THE STUDY REPORTED THAT A PATIENT IN THE REVISION COHORT SUBSEQUENTLY EXPERIENCED RECURRENT DISLOCATIONS. A MINOR REVISION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175631 UNKNOWN HEAD PROSTHESIS, HIPS LPH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention| H SEE H11 NARRATIVE