BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL HD 32 12/14 SZXL/+7 L/+7

    MDR report key: 16673042 · Received April 4, 2023

    Report

    Report Number
    0009613350-2023-00153
    Event Type
    Injury
    Date Received
    April 4, 2023
    Report Date
    July 12, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    UDI-DI
    00889024507166
    PMA / PMN Number
    K091973
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL DEVICES: METASUL TAPER LINER GG/32; ITEM# 00877000832; LOT# 2519862; 48MM O.D. SIZE GG POROUS UNCEMENTED WITH UNI-HOLE SHELL USE WITH GG LINERS; ITEM# 00875704800; LOT# 61403509. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00154. LOCATION OF THE PRODUCT IS UNKNOWN HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED PRODUCT: FEMORAL STEM FIBER METAL TAPER COLLARLESS 12/14 NECK TAPER WITH CALCICOAT CERAMIC COATING SIZE 13 STANDARD BODY EXTENDED NECK OFFSET; ITEM# 65-7862-013-20; LOT# 60180218. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A DISLOCATION, APPROXIMATELY EIGHT (8) YEARS AFTER THE INITIAL HIP ARTHROPLASTY. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT 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
    1144529 METASUL HD 32 12/14 SZXL/+7 L/+7 PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) KWA ZIMMER SWITZERLAND MANUFACTURING GMBH 2518834 00889024507166

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R