BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET RINGLOC+ ACETABULAR SHELL

    MDR report key: 7249202 · Received February 7, 2018

    Report

    Report Number
    0001825034-2018-00376
    Event Type
    Injury
    Date Received
    February 7, 2018
    Date of Event
    February 13, 2011
    Report Date
    March 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK093235
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01649-1, 0001825034-2018-00377-2, 0001825034-2018-00376-2.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM# 11-363662, FEMORAL HEAD, LOT# 047130. ITEM# 14-103201, TAPERLOC STEM, LOT # 606010. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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. MULTIPLE REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00376-1, 0001825034-2018-00377-1, 00018.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR EVALUATION, DUE TO THE IMPLANT REMAINS IMPLANTED. THE EVALUATION IS IN PROCESS. ONCE THE EVALUATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MAUDE REPORT MW5073429. PRODUCT REMAINS IMPLANTED. EP-108323 E1 POLY LINER LOT # 301360. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00376, 00377. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT STARTED EXPERIENCING PAIN 4 YEARS POST IMPLANTATION. THE PATIENT IS EXPERIENCING WORSENING PAIN, A LIMP, AMBULATION DIFFICULTIES, MUSCLE SPASMS, MUSCLE DAMAGE, AND NUMBNESS FROM HIP DOWN TO TOES FOR THE PAST 2 YEARS. PATIENT ALSO ALLEGES THAT THE HIP "TRIED TO DISLOCATE" ON TWO OCCASIONS. PATIENT REPORTS BEING PRESCRIBED PERCOCET FOR PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT STARTED EXPERIENCING PAIN 4 YEARS POST IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT IS EXPERIENCING WORSENING PAIN, A LIMP, AMBULATION DIFFICULTIES, MUSCLE SPASMS, MUSCLE DAMAGE, AND NUMBNESS FROM HIP DOWN TO TOES FOR THE PAST 2 YEARS. PATIENT ALSO ALLEGES THAT THE HIP "TRIED TO DISLOCATE" ON TWO OCCASIONS. PATIENT REPORTS BEING PRESCRIBED PERCOCET FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93630 BIOMET RINGLOC+ ACETABULAR SHELL HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 847500

    Patients

    Seq Age Sex Outcome Treatment
    1 Other