BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X38MM

    MDR report key: 11761270 · Received May 3, 2021

    Report

    Report Number
    0001825034-2021-01334
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    December 16, 2020
    Report Date
    May 11, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304485020
    PMA / PMN Number
    K161190
    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

    AN ACT ARTIC E1 HIP BRG 28X38MM, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND SIGNIFICANT SCRATCHING NEAR THE APEX OF THE BEARING WITH LIGHTER SCRATCHING AROUND THE RADIUS. CLUSTERS OF PITS WERE ALSO SPORADICALLY OBSERVED AROUND THE OUTER RADIUS. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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 00801802803 ITEM NAME FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER LOT # 62516835. PRODUCT 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: 0001825034 - 2020 - 04439.

    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
    658413 ACT ARTIC E1 HIP BRG 28X38MM PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 578620 00880304485020

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R