BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 FP 12/14 BM SO 10.0

    MDR report key: 8458008 · Received March 27, 2019

    Report

    Report Number
    0001825034-2019-01364
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    February 25, 2019
    Report Date
    May 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SURGEON NOTES THERE WAS A WOUND DEHISCENCE OCCURRED AT SOME POINT. THERE WAS WASHOUTS (I&DS) PERFORMED & ANTIBIOTIC TREATMENTS GIVEN TILL REVISION WAS DONE. INFECTION (KLEBSIELLA) WAS CULTURED FROM THE ACETABULUM ONLY. INFECTION OCCURRED WITHIN 1 YR POST PROCEDURE. KLEBISELLA IS A KNOWN BACTERIA TO BE RELATED TO JOINT INFECTIONS, AS WELL AS PNEUMONIA, URINARY TRACT INFECTIONS AND BLOOD INFECTIONS. IT IS UNKNOWN IF THE PATIENT HAD AN EXISTING INFECTION WHILE THE INITIAL PROCEDURE WAS PERFORMED, WHICH COULD BE A CONTRIBUTING FACTOR AS WELL AS PATIENT WAS NOTED TO BE MORBID OBESE, WHICH INCREASES THE RISK FOR INFECTIONS POST OP. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 010000662, G7 PPS LTD ACET SHELL 50D, LOT# 6289152; ITEM# 010000856, G7 NEUTRAL E1 LINER 36MM, D LOT# 6289818; ITEM# 010000998, G7 SCREW 6.5MM X 25MM, LOT# 6238952; ITEM# 010000996, G7 SCREW 6.5MM X 15MM, LOT# 3716836; ITEM#650-0836, BIOLOXDELTAMODULARCERAMICHEAD 32MM-4MMNECK TYPE12/14TAPER, LOT# 2018012043. REPORT SOURCE: FOREIGN SOURCE- (B)(6). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K101086. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. 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 -2019 -01367, 0001825034 -2019 -01365, 0001825034 -2019 -01363, 0001825034 -2019 -01362.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP ARTHROPLASTY REVISION DUE TO INFECTION APPROXIMATELY 9 MONTHS POST INITIAL IMPLANTATION. PATIENT WAS REPORTEDLY TREATED WITH MULTIPLE WASHOUTS AND ANTIBIOTIC TREATMENTS WITHOUT SUCCESS, PRIOR TO EXPLANTATION OF THE IMPLANTS. PATIENT SUBSEQUENTLY PASSED AWAY A FEW DAYS AFTER THE REVISION PROCEDURE DUE TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251634 TPRLC 133 FP 12/14 BM SO 10.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6246373

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R