BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S1S HIP HEAD CEMENT MOLD

    MDR report key: 7768895 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-07890
    Event Type
    Injury
    Date Received
    August 9, 2018
    Report Date
    October 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWL
    PMA / PMN Number
    PK080979
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 431186 HIP MOLS NECK ADAPTER LOT UNK, 431192 HIP MOLD STEM W/REINF LOT UNK, UNK, UNKNOWN BONE CEMENT, LOT UNK. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: ITEM # 51-107200, STEM, LOT # 3140308; ITEM # 650-1057, HEAD, LOT # 893830; ITEM # 010000860, LINER, LOT # 3266167; ITEM # 650-1064, TAPER SLEVE, LOT # 411520. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 07887, 0001825034 - 2018 - 07888, 0001825034 - 2018 - 07889, 0001825034 - 2018 - 07891.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST IMPLANTATION, THE PATIENT SUSTAINED A FALL, WAS ADMITTED TO THE HOSPITAL, AND FOUND TO BE SEPTIC. NO NOTATION OF ANY CULTURE RESULTS. PICC LINE WAS PLACED FOR ADMINISTRATION OF IV ANTIBIOTICS. THE PATIENT SUBSEQUENTLY DEVELOPED A DVT BEHIND THE PICC LINE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610692 S1S HIP HEAD CEMENT MOLD PROSTHESIS, HIP KWL ZIMMER BIOMET, INC. N/A 3147335

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R