BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW

    MDR report key: 6740879 · Received July 25, 2017

    Report

    Report Number
    0001825034-2017-05193
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    January 16, 2017
    Report Date
    April 18, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, (KEPT BY PATIENT/HOSPITAL). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. XRAY REVIEW BY HEALTH CARE PROFESSIONAL REPORTED NINE YEARS POST IMPLANTATION RADIOGRAPHS SHOW A REGION OF PERIPROSTHETIC LUCENCY SURROUNDING THE ACETABULAR SCREW. CONCOMITANT PRODUCT: M2A HI CARBON MODULAR HEAD P/N 11-163679 L/N 902340; M2A HI CARBON TAPER LINER P/N 15-105011 L/N 841770; UNKNOWN SCREW P/N UNKNOWN L/N UNKNOWN. REPORT SOURCE ¿ (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-00390. 0001825034-2017-00391. 0001825034-2017-05192. 0001825034-2017-05193. RETAINED BY PATIENT/HOSPITAL

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: 11-163679 28MM M2A HI CARBON HD +3MM NK 902340; 15-105011 M2A TPR HI CARBON 37/28MM LNR 841770; 103531 TI LOW PROFILE SCREW 6.5X20MM 845130; 103531 TI LOW PROFILE SCREW 6.5X20MM 845150; 10-104050 M2A-T M/H RAD 2HL SHL 37/50MM 587360; X11-180440 BI METRIC/XR LAT RPP C/L 10MM 607080. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEDICATED IMAGES 9 YEARS AFTER PRIMARY OPERATION OF THE RIGHT HIP CONFIRMS A ZONE OF LUCENCY SURROUNDING THE ACETABULAR SCREWS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT¿S RIGHT HIP WAS REVISED APPROXIMATELY 10 YEARS POST-IMPLANTATION DUE TO PAIN AND EVIDENCE OF A PSEUDOTUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522973 TI LOW PROFILE SCREW PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 845150

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R SEE H10