BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 38MM C

    MDR report key: 11100926 · Received December 31, 2020

    Report

    Report Number
    0001825034-2020-04439
    Event Type
    Injury
    Date Received
    December 31, 2020
    Date of Event
    December 16, 2020
    Report Date
    May 10, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A G7 DUAL MOBILITY LINER 38MM, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. THE INNER RADIUS WAS FOUND TO BE SCUFFED AND SCRATCHED. THE RIM OF THE LINER HAS BEEN DENTED IN THE SAME LOCATION THAT SCRATCHING APPEARS ON THE RIM OF THE SHELL. WHEN A FINGER IS RUBBED OVER THE OPEN FACE OF THE SHELL/LINER ASSEMBLY, THE RIM OF THE LINER CAN BE FELT PROTRUDING OVER THE RIM OF THE SHELL. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: (SUMMARIZED BY HCP) MMI REVIEW: INITIAL NORMAL POSTOPERATIVE APPEARANCE OF RIGHT TOTAL HIP ARTHROPLASTY WITH FOLLOW-UP IMAGE DEMONSTRATING DISLOCATION OF THE FEMORAL COMPONENT SUPEROLATERALLY WITH RESPECT TO THE ACETABULAR CUP. A DEFINITIVE ROOT CAUSE CANNOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-01334.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER 00811400110 ITEM NAME FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 1 130 MM STEM LENGTH LOT # 64609268. ITEM NUMBER 010000701 ITEM NAME G7 BONEMASTER LTD ACET SHL 48C LOT # 6749838. ITEM NUMBER EP-200144 ITEM NAME ACT ARTIC E1 HIP BRG 28X38MM LOT # 578620. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920 -2020 -00544.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO DISLOCATION. PATIENT FELL FROM A CHAIR CAUSING THE HIP TO DISLOCATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565299 G7 DUAL MOBILITY LINER 38MM C PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 814550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE