BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER

    MDR report key: 16271564 · Received January 31, 2023

    Report

    Report Number
    0002648920-2023-00007
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    October 8, 2018
    Report Date
    March 23, 2023
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT# 00-2232-004-18 LOT# 63674177 CABLE READY GTR COCR CABLE, CAT#00-2232-004-18 LOT# 63716290 CABLE READY GTR COCR CABLE, CAT# 00-6202-058-22 LOT# 63365727 TM ACET SHELL 58MM CLUSTER, CAT# 00-7713-013-00 LOT# 63675172 M/L TPR KINECTIV STEM SZ 13.5. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2023 - 00172, 0001822565 - 2023 - 00260. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORTS WERE FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY THE PATIENT NOTED THEY WERE REVISED APPROXIMATELY ONE (1) YEAR LATER DUE TO WORN POLY. MEDICAL RECORDS SHOW REVISION DUE TO PAIN AND HEMATOMA FROM AN UNKNOWN INJURY TO LEFT LEG. DURING THE REVISION, THE SURGEON NOTED METALLOSIS, SCARRING, AND LOCAL TISSUE REACTION. THE HEAD, NECK, AND LINER WERE EXCHANGED, THE CERCLAGE WIRES WERE REMOVED AND IRRIGATION AND DEBRIDEMENT TO HEMATOMA WITHOUT COMPLICATIONS. SUBSEQUENTLY AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED APPROXIMATELY SEVEN (7) MONTHS AFTER REVISION DUE TO RECURRENT HEMATOMA WITH THREE (3) PREVIOUS ASPIRATIONS WITH NEGATIVE CULTURES. THE LARGE HEMATOMA WAS EXCISED WITH DRAIN PLACED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105635 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 63283898

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H