BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULOX-HEAD 28 M 12/14

    MDR report key: 8481469 · Received April 4, 2019

    Report

    Report Number
    0009613350-2019-00187
    Event Type
    Injury
    Date Received
    April 4, 2019
    Date of Event
    February 21, 2019
    Report Date
    June 25, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: IMPLANT BREAKAGE. EVENT DESCRIPTION: IT WAS REPORTED THAT THE 85 YEARS OLD FEMALE PATIENT, BMI=28.6, HAD AN IMPLANTATION OF A CEMENTLESS HIP PROSTHESIS ON (B)(6) 2002. SHE WAS SYMPTOM-FREE SO FAR. ON (B)(6) 2019 SHE SUDDENLY HAD EXACERBATION LASTING ASSOCIATED WITH A LOUD CRACKING NOISE IN THE LEFT HIP JOINT DURING SITTING. THE CT EXAMINATION SHOWED A BROKEN SULOX-HEAD AND PE ABRASION. DURING THE REVISION SURGERY ON (B)(6) 2019 A BROKEN SULOX-HEAD WAS NOTICED, HEAD AND INSERT WERE REPLACED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICE ANALYSIS: NO DEVICE RETURNED. REVIEW OF PRODUCT DOCUMENTATION: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. SURGICAL TECHNIQUE WAS NOT REVIEWED AS NO PRIMARY OP NOTES OR X-RAYS WERE PROVIDED TO COMPARE. CONCLUSION: BASED ON THE GIVEN INFORMATION THE COMPLAINT COULD NOT BE CONFIRMED AS NO PRODUCT NOR MEDICAL NOTES WERE PROVIDED FOR EVIDENCE. THE QUALITY RECORDS OF THE SULOX HEAD SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. HOWEVER, DHR REVIEW OF THE INSERT COLD NOT BE DONE AS NO LOT NO WAS REPORTED. DETAILED INVESTIGATION COULD NOT BE DONE DUE TO ABSENCE OF REQUIRED INFORMATION. THEREFORE, NO ROOT CAUSE COULD BE IDENTIFIED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    PLEASE REFER TO REPORT .

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM# 17.28.06, LOT# 2136518, SULOX-HEAD 28 M 12/14; ITEM# 2252, LOT# UNKNOWN, PE INSERT LAMELLA 50/28. PREMARKET IDENTIFICATION: THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K923808. DEVICE EVALUATION: THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED AT THE TIME OF THIS INITIAL REPORT; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, APPROXIMATELY 16 YEAR POST IMPLANTATION, THE PATIENT EXPERIENCED SUDDEN PAIN EXACERBATION WITH A LOUD CRACKING NOISE IN THE LEFT HIP AFTER SITTING DONE AT HOME. CT EXAMINATIONS SHOW A FRACTURED CERAMIC HEAD AND PE ABRASION. THEREFORE A REVISION TOOK PLACE. THE FRACTURE COULD BE CONFIRMED INTRA-OPERATIVELY AND THE DEVICES WERE REMOVED AND EXCHANGED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276956 SULOX-HEAD 28 M 12/14 N/A LPH ZIMMER GMBH N/A 2136518

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R