BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULOX, HEAD, M, 32/0, TAPER 12/14

    MDR report key: 6889698 · Received September 25, 2017

    Report

    Report Number
    0009613350-2017-01318
    Event Type
    Injury
    Date Received
    September 25, 2017
    Date of Event
    August 29, 2017
    Report Date
    March 28, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFOR TRIED SEVERAL TIMES TO RECEIVE MORE INFORMATION FOR THIS CASE, THE LATEST ONE ON FEBRUARY 25, 2018. ADDITIONAL INFORMATION IS CURRENTLY NOT AVAILABLE. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: FRACTURED SULOX HEAD. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. E-MAILS REQUESTING MISSING DEVICE DATA INFORMATION WERE SENT TO THE COMPLAINANT, THE LATEST ONE ON FEBRUARY 25, 2018. AT ZIMMER GMBH ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER GMBH AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. EVENT SUMMARY: IT WAS REPORTED THAT WHILE DESCENDING FROM A LADDER, THE PATIENT HAS FELT A SUDDON CRACKING / TEARING IN THE AREA OF THE RIGHT HIP AND IS EXPERIENCING STRONG PAIN ON (B)(6) 2017. DURING INVESTIGATION IT WAS FOUND THAT THE SULOX-HEAD 32MM 12/14 HAD FRACTURED AND HAS BEEN REVISED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS AS IT IS RETAINED BY THE PATIENT. REVIEW OF PRODUCT DOCUMENTATION DURING INVESTIGATION, THE PART NUMBER OF THE PRODUCT WAS DETERMINED TO BE 17.32.06 (SULOX-HEAD 32/0 "M" 12/14). INSTRUCTION FOR USE (IFU): THE PACKAGING INSERT D011500200 HAS BEEN REVIEWED. IT IS EXPLAINED "THE PATIENT MUST BE INSTRUCTED AS TO THE LIMITS OF THE IMPLANT AS WELL AS ITS LOWER LOADABILITY, THE RANGE OF MOTION AND THE PERMISSIBLE LEVEL OF ACTIVITY. EARLY WEIGHT-BEARING MUST BE CAREFULLY CONTROLLED." AN IMPLANT FRACTURE IS LISTED AS A POSSIBLE ADVERSE EVENT. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA: FRACTURE OF HEAD DUE TO FRACTURE OF HEAD DUE TO INSUFFICIENT MATERIAL THICKNESS (WRONG DESIGN) NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. LOSS OF CONNECTION, FRACTURE OF CERAMIC HEAD DUE TO INAPPROPRIATE DESIGN CONCERNING PULL-OFF/TORQUE STRENGTH OF THE HEAD ON THE STEM TAPER NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. LOSS OF CONNECTION, FRACTURE OF CERAMIC HEAD DUE TO PARTICLES BETWEEN STEM AND HEAD TAPER = POSSIBLE: IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. IT IS UNKNOWN, WHETHER THE INFORMATION GIVEN IN THE PACKAGE INSERT HAS BEEN FOLLOWED. FRACTURE OF HEAD TO DUE STEM TAPER CORROSION (INCREASING OF VOLUME) DUE TO WRONG MATERIAL PAIRING POSSIBLE: IT REMAINS UNKNOWN, WHICH STEM HAS BEEN IMPLANTED. HOWEVER, ZIMMER BIOMET'S IMPLANTS FULFILL THE MATERIAL COMPATIBILITY SPECIFICATION. IMPLANT DAMAGE, COMPROMISED IMPLANT FIXATION DUE TO IMPACTION FORCE BY ASSEMBLING HEAD ON STEM TAPER POSSIBLE: IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. IT IS UNKNOWN, WHETHER THE INFORMATION GIVEN IN THE PACKAGING INSERT HAS BEEN FOLLOWED. MAL-FUNCTION OF THA (WEAR, FRACTURE, DISLOCATION ETC.) DUE TO WRONG SIZE OF HEAD DIAMETER AND/OR OFFSET POSSIBLE: AS NO X-RAYS OR SURGICAL REPORT HAS BEEN RECEIVED, IT CANNOT BE EXCLUDED THAT A WRONG SIZE HAS BEEN IMPLANTED. HIGH WEAR, HEAD FRACTURE DUE TO WRONG RAW MATERIAL SELECTION NOT POSSIBLE: A SYSTEMATIC ISSUE WITH MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT DEFINED IN COMPLAINT INVESTIGATION OR IN THE CURRENT PMS PROCESS. COMPROMISED TAPER FIXATION STRENGTH, FRACTURE OF IMPLANT DUE TO HIGH PATIENT ACTIVITY, PATIENT DISREGARDS LIMITS OF THE DEVICE POSSIBLE: IT HAS BEEN REPORTED THAT PATIENT HAS DESCENDED FROM A LADDER WHEN THE IMPLANT FRACTURED. LOSS OF CONNECTION, FRACTURE OF CERAMIC HEAD DUE TO USE ON A USED OR DAMAGED STEM TAPER POSSIBLE: DUE TO THE LACK OF INFORMATION THIS CANNOT BE EXCLUDED. IT IS UNKNOWN, IT IS UNKNOWN, WHETHER THE INFORMATION GIVEN IN THE PACKAGE INSERT HAS BEEN FOLLOWED. PATIENT BEHAVIOR LEADS TO PREMATURE FAILURE DUE TO INADEQUATE INFORMATION DURING PATIENTS COUNSELING BY SURGEON => POSSIBLE: DUE TO THE LACK OF INFORMATION THIS CANNOT BE EXCLUDED. IT IS UNKNOWN, IT IS UNKNOWN, WHETHER THE INFORMATION GIVEN IN THE PACKAGE INSERT HAS BEEN FOLLOWED. COMPROMISED TAPER FIXATION STRENGTH, FRACTURE OF IMPLANT DUE TO HIGH PATIENT ACTIVITY, PATIENT DISREGARDS LIMITS OF THE DEVICE => POSSIBLE: IT HAS BEEN REPORTED THAT PATIENT HAS DESCENDED FROM A LADDER WHEN THE IMPLANT FRACTURED. THE PACKAGING INSERT SHOULD BE CONSIDERED. CONCLUSION SUMMARY: IT WAS REPORTED THAT A PATIENT HAD BEEN IMPLANTED WITH AN SULOX-HEAD 32MM 12/14 ON AN UNKNOWN DATE WHICH HAS BEEN REVISED DUE TO AN IMPLANT FRACTURE. THE PATIENT FELT THE CRACKING / TEARING IN THE AREA OF THE RIGHT HIP WHILE DESCENDING FROM A LADDER ON 30 AUG 2017. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED. IT IS DEFINED IN THE PACKAGING INSERT, THAT THE PATIENT MUST BE INSTRUCTED AS TO THE LIMITS OF THE IMPLANT AS WELL AS ITS LOWER LOAD-ABILITY, THE RANGE OF MOTION AND THE PERMISSIBLE LEVEL OF ACTIVITY. THEREFORE ONE POSSIBLE ROOT CAUSE MIGHT BE THAT THE PATIENT DISREGARDED THE LIMITS OF THE DEVICE WHEN DESCENDING FROM THE LADDER. HOWEVER, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E BIOLOX-FORTE HEAD 28/-3.5 M 12/14 510K#923808) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER BIOMET CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    PATIENT WAS REVISED AFTER UNKNOWN TIME IN VIVO DUE TO BREAKAGE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE 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 THE PATIENT WAS IMPLANTED A SULOX-HEAD 32 MM 12/14 ON THE RIGHT SIDE ON AN UNKNOWN DATE. CURRENTLY, THE PATIENT IS BEING MONITORED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669564 SULOX, HEAD, M, 32/0, TAPER 12/14 SULOX-HEAD LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R