BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCR 6.5X40 SELF-TAP

    MDR report key: 12149626 · Received July 12, 2021

    Report

    Report Number
    0001825034-2021-02009
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    May 28, 2021
    Report Date
    March 30, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. 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 · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE SCREW WAS DETERMINED TO BE NOT REPORTABLE AS THE DEVICE IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE SCREW WAS DETERMINED TO BE NOT REPORTABLE AS THE DEVICE IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: REF 110024466 LOT 609930 G7 METAL LINER; REF XL-200156 LOT 876400 ACTIVE ARTICULATION BEARING; REF 163663 LOT 557030 HEAD; REF 110024456 LOT 029180 DUAL MOBILITY LINER; REF 163663 LOT 624200 MODULAR HEAD 28MM +3 NECK; REF 110010269 LOT 6831221 G7 SHELL; REF 00625006540 LOT J6730167 SCREW; REF 00625006540 LOT J6694869 SCREW; REF 11-301322 LOT 013220 PROXIMAL BODY; REF 11-300921 LOT 032370 DISTAL STEM; REF 11-302138 LOT 420950 TROCHANTERIC BOLT; REF 11-302109 LOT 583360 TROCHANTERIC BUTTON. 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 - 2021 - 02008, 0001825034 - 2021 - 02010, 0001825034 - 2021 - 02011, 0001825034 - 2021 - 02012, 0001825034 - 2021 - 02013, 0001825034 - 2021 - 02015, 0001825034 - 2021 - 02016, 0001825034 - 2021 - 02017, 0001825034 - 2021 - 02018, 0001825034 - 2021 - 02020, 0001825034 - 2021 - 02022, 0001825034 - 2021 - 02023.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INITIAL UNKNOWN RIGHT TOTAL HIP ARTHROPLASTY PLACED APPROXIMATELY 22 YEARS AGO. THE PATIENT WAS REVISED DUE TO POLY WEAR AND ACETABULAR OSTEOLYSIS. AFTER THE REVISION, THE PATIENT EXPERIENCED ISSUES WITH HEALING AT THE INCISION SITE. AN I&D WITH EXCHANGE OF THE DUAL MOBILITY COMPONENTS WAS PERFORMED 2 MONTHS LATER DUE TO INFECTION. THE PATIENT CONTINUED TO EXPERIENCE ELEVATED LABS AND DRAINAGE CONCERNS. THE PATIENT WAS AGAIN REVISED WITHIN THE MONTH FOR DEEP INFECTION WITH GROSS PURULENCE IN THE JOINT. ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WITH CONSTRAINED CUP AND LINER PLACED WITHOUT COMPLICATION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046235 BONE SCR 6.5X40 SELF-TAP PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A J6851911

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Hospitalization| R