BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE ARTICULATION E1 HIP BEARING

    MDR report key: 11176767 · Received January 15, 2021

    Report

    Report Number
    0001825034-2021-00068
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    December 22, 2020
    Report Date
    April 8, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K161190
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11: PART # 00801802801 / HEAD/ LOT # 64521813, PART # 110024462 / LINER/ LOT # 812450, PART #010000996/ G7 SCREW/ LOT # 6596542, PART #0106010103/ AVENIR® MüLLER, STEM/ LOT # 2854319, PART # 010000998/ SCREW/ LOT #6833035, PART # 010000999/ SCREW/ LOT #6837769.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THEREFORE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE IMPLANTED ZIMMER BIOMET PRODUCT. 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

    IT WAS REPORTED THAT DURING PATIENT WAS REVISED ONE-MONTH POST IMPLANTATION DUE INFECTION. THE SURGEON DID A WOUND DEBRIDEMENT AND EXCHANGED THE HEAD AND LINER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    CMP (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS: PART # UNKNOWN / UNKNOWN HEAD/ LOT # UNKNOWN PART #UNKNOWN / UNKNOWN CUP/ LOT # UNKNOWN PART #UNKNOWN / UNKNOWN STEM/ LOT # UNKNOWN, (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2021 -00069

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT WAS REVISED ONE-MONTH POST IMPLANTATION DUE TO WOUND COMPLICATIONS. HEAD AND LINER WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73202 ACTIVE ARTICULATION E1 HIP BEARING PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. NI 964730

    Patients

    Seq Age Sex Outcome Treatment
    1