BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14

    MDR report key: 7333442 · Received March 13, 2018

    Report

    Report Number
    0009613350-2018-00347
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    February 13, 2018
    Report Date
    August 24, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: DURASUL, ALPHA INSERT, KK/36 REF# 01.00013.711, LOT#2884269; ALLOFIT ALLOCLASSIC SHL 56/KK, REF#4247, LOT# 2889770; AVENIR MUELLER, STEM, STANDARD, UNCEMENTED, HA, 3, TAPER 12/14, REF# 0106010003, LOT#: 2841592. THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2018-003476. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. NO SURGICAL REPORT OR X-RAYS WERE PROVIDED FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. .

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. 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: DISLOCATION. EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT WOULD LEAN FOR WARD AND HIP WOULD START TO DISLOCATE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION SURGERY AROUND 7 MONTHS POST IMPLANTATION. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICE ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING SAP RMW : LOSS OF INSERT-SHELL CONNECTION, COMPONENT LOOSENING, DISLOCATION DUE TO INSUFFICIENT INSERT STABILITY DUE TO DESIGN (SNAP GEOMETRY) NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. METAL DEBRIS, BREAKAGE OF INSERT, STEM NECK FRACTURE, DISLOCATION OR LUXATION, OSTEOLYSIS / METALLOSIS DUE TO INAPPROPRIATE INSERT DESIGN CONCERNING RANGE OF MOTION (E.G. HOODED INSERTS) LEADING TO IMPINGEMENT OF COMPONENTS. NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. INCOMPLETE INSERT FIXATION IN SHELL LEADING TO POSTOP COMPLICATIONS (INSERT DISLOCATION, LOOSENING, FRACTURE DUE TO WRONG OR INCOMPLETE INSPECTION => POSSIBLE, NO DATA/INFO (E.G. SURGICAL REPORT OF IMPLANTATION) WERE RECEIVED FOR EVALUATION OF IMPLANTING SCENARIO. THEREFORE THIS CAUSE CANNOT BE EXCLUDED. CONCLUSION: IT WAS REPORTED THAT A PATIENT EXPERIENCED A DISLOCATION AND UNDERWENT SUBSEQUENTLY A REVISION SURGERY. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION SURGERY DUE TO DISLOCATION AFTER APPROXIMATELY 7 MONTHS IN VIVO. THE SURGEON CHOOSE TO REPLACE THE HEAD WITH BIOBALL IMPLANTS TO INCREASE OFFSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177425 BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2880096

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R