BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR CMPL HA HO COL SIZE 3

    MDR report key: 12085766 · Received June 29, 2021

    Report

    Report Number
    0001822565-2021-01782
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    June 6, 2021
    Report Date
    September 3, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K182048
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, G3, H2, H3, H4, H6. REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THAT PATIENT FELL AND SUSTAINED A RIGHT ACETABULAR FRACTURE AND A PERIPROSTHETIC FEMUR FRACTURE AROUND THE FEMORAL STEM; THIS WAS AN EARLY POSTOPERATIVE FRACTURE SO THE STEM WAS NOT INGROWN. CABLES PLACED AROUND THE FEMUR, CULTURES TAKEN FROM ACETABULUM. CUP LEFT IN PLACE, ALL OTHER COMPONENTS REVISED WITHOUT COMPLICATION. IT WAS REPORTED THAT THE PATIENT FELL. HOWEVER, THE REASON FOR THE FALL IS UNKNOWN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 1 WEEK POST IMPLANTATION DUE TO FEMORAL AND ACETABULAR PERIPROSTHETIC FRACTURES FROM A FALL. THE CUP REMAINED INTACT. ALL OTHER COMPONENTS WERE REPLACED WITHOUT COMPLICATION. NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT# 30103604 G7 VIT E NEUTRAL LNR 36MM D LOT# 65052206. CAT# 00877503604 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, ø 36/+7, TAPER 12/14 LOT# 3052293. CAT# 010000662 G7 PPS LTD ACET SHELL 50D LOT# 6966419. 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: 0001825034-2021-01915.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY APPROXIMATELY 1 MONTH AGO AND WAS REVISED ON AN UNKNOWN DATE DUE TO A FEMORAL AND ACETABULAR PERIPROSTHETIC FRACTURES. NO FALLS OR TRAUMATIC EVENTS WERE REPORTED. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981415 AVENIR CMPL HA HO COL SIZE 3 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3044581

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE