BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH

    MDR report key: 8921461 · Received August 22, 2019

    Report

    Report Number
    0002648920-2019-00629
    Event Type
    Injury
    Date Received
    August 22, 2019
    Report Date
    September 25, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    K960658
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS NOTED DRAINAGE FROM THE SURGICAL SITE WITH REDNESS AND POOR APPROXIMATION AT THE DISTAL INCISION. A WEEK LATER, THERE WAS A SLIGHT SECRETION FROM DISTAL SECTION OF WOUND. AFTER REMOVING THE SUTURES AND MONITORING FOR A FEW DAYS WITHOUT ANTIBIOTIC TREATMENT, THE SECRETION STOPPED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. AGE OR DATE OF BIRTH: BORN IN (B)(6). UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART: 00-8114-001-00, FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH, LOT: 63735436; PART: 00801802230, FEMORAL HEAD 12/14 TAPER, LOT: 63677745; PART: P0463048, AVAN CMNTD SHELL SS 48MM, LOT: 0001105980; PART: P0560048, AVAN INSERT 48/22, LOT: 0001102705; PART: 4711500396-1, OPTIPAC-S 60 REFOB BN CMT R, LOT: B708C05355; PART: 4711500693-1, OPTIPAC-S 60 REFOB BN CMT R, LOT: A710B05615. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2019-00630.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY AND SUBSEQUENTLY, THE PATIENT EXPERIENCED REDNESS AND DRAINAGE FROM THE SURGICAL SITE. THE PATIENT WAS PLACED ON PROPHYLACTIC ANTIBIOTICS, AND WAS ADMITTED FOR OBSERVATION TO RULE OUT INFECTION APPROXIMATELY TWO POST-IMPLANTATION. INFECTION WAS RULED OUT, AND THE DRAINAGE DISCONTINUED WITHOUT FURTHER COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714846 FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 63735436

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R SEE H10