BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULOX, HEAD, S, 32/-3.5, TAPER 12/14

    MDR report key: 9178409 · Received October 11, 2019

    Report

    Report Number
    0009613350-2019-00605
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    March 5, 2019
    Report Date
    January 15, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ON INVESTIGATION RESULT. DHR-REVIEW: REF#: 2885, LOT#: 2553313, YIELD: 10, DELIVERED: 10. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: PART SPECIFIC INVESTIGATION: NO ADDITIONAL SIMILAR INVESTIGATED EVENTS (INFECTION, LOOSENING) WITHIN LAST 1 MONTH FOR ITEM NUMBERS: 2885, 3534, 0100126658 AND 173205 HAVE BEEN FOUND. NO ADDITIONAL SIMILAR INVESTIGATED EVENTS (INFECTION, LOOSENING) WITHIN LAST 6 MONTHS FOR ITEM NUMBER: 2885, 3534, 0100126658 AND 173205 HAVE BEEN FOUND. RESULT: ISSUE EVALUATION REQUEST IS NOT REQUIRED. LOT SPECIFIC INVESTIGATION: 3 (OR MORE) SIMILAR INVESTIGATED EVENTS FOR THE SAME LOT NUMBER? NO SIMILAR INVESTIGATED EVENTS (INFECTION, LOOSENING) FOR THE SAME LOT NUMBER: 2553313 HAVE BEEN FOUND. NO SIMILAR INVESTIGATED EVENTS (INFECTION, LOOSENING) FOR THE SAME LOT NUMBER: 2484894 HAVE BEEN FOUND. NO SIMILAR INVESTIGATED EVENTS (INFECTION, LOOSENING) FOR THE SAME LOT NUMBER: 2474598 HAVE BEEN FOUND. NO SIMILAR INVESTIGATED EVENTS (INFECTION, LOOSENING) FOR THE SAME LOT NUMBER: 2566288 HAVE BEEN FOUND. RESULT: ISSUE EVALUATION REQUEST IS NOT REQUIRED. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A TOTAL HIP PROSTHESIS ON (B)(6) 2009. THE FIRST REVISION OF STEM AND HEAD TOOK PLACE ON (B)(6) 2010 (SEE (B)(4). THE SECOND REVISION OF ALL IMPLANTS TOOK PLACE ON (B)(6) 2019 DUE TO INFECTION (ASPIRATION POS. FOR STAPH EPIDERMIDIS). MOREOVER, A BONE SCAN PERFORMED ON (B)(6) 2018 WOULD HAVE SHOWN LOOSENING OF CUP AND STEM. REVIEW OF RECEIVED DATA: X-RAY: SIX X-RAYS HAVE BEEN RECEIVED AND EVALUATED BY AN HCP FROM MEDICAL METRICS. SIX VIEWS OF THE LEFT HIP DEMONSTRATE A LEFT TOTAL HIP ARTHROPLASTY WITH CEMENT FIXATION OF THE ACETABULAR CUP AS WELL AS TWO CERCLAGE WIRE IS ALONG THE FEMORAL STEM. RADIOLUCENCY ALONG THE PROXIMAL FEMORAL COMPONENT IS IDENTIFIED ON IMAGE ONE AND PROGRESSES THROUGH IMAGE SIX WHERE THERE APPEARS TO BE LUCENCY ALONG THE DISTAL CERCLAGE WIRE. THE TIP OF THE FEMORAL STEM IS NOT SEEN ON IMAGE SIX BUT IS SEEN ON IMAGE FIVE WITHOUT RADIOLUCENCY. NOTE IS ALSO MADE OF DEVELOPING PERIOSTITIS ALONG THE PROXIMAL FEMORAL DIAPHYSIS WHICH COULD INDICATE UNDERLYING HARDWARE LOOSENING. ADDITIONAL NOTE IS MADE OF PROGRESSIVE RADIOLUCENCY ALONG THE MEDIAL AND SUPERIOR ACETABULAR NOT SEEN ON IMAGE ONE BUT SEEN ON IMAGE TWO AND PERSISTING THROUGH IMAGE SIX. PROGRESSIVE LOOSENING OF THE FEMORAL STEM ALONG WITH POSSIBLE PROGRESSIVE LOOSENING OF THE ACETABULAR COMPONENT, AS DESCRIBED ABOVE. OVERALL FIT AND ALIGNMENT OF THE IMPLANTS IS APPROPRIATE. ACETABULAR INCLINATION ANGLE OF THE LEFT HIP: 46°. PROGRESSIVE LOOSENING OF THE FEMORAL COMPONENT IS SEEN IN ADDITION TO LUCENCY ALONG THE MEDIAL AND SUPERIOR ACETABULUM. NOTE IS ALSO MADE OF DEVELOPING PERIOSTITIS ALONG THE PROXIMAL FEMUR DIAPHYSIS WHICH COULD INDICATE UNDERLYING HARDWARE LOOSENING. THERE IS PROGRESSIVE LUCENCY ALONG THE MEDIAL AND SUPERIOR ACETABULUM BEGINNING ON IMAGE TWO THROUGH IMAGE SIX WHICH COULD INDICATE OSTEOLYSIS. INITIAL IMPLANTATION REPORT DATED ON (B)(6) 2009. DIAGNOSIS: COXARTHROSIS LEFT HIP SIDE. PROCEDURE: CEMENTLESS TOTAL HIP PROCEDURE. NO COMPLICATIONS ARE NOTED. FIRST REVISION REPORT DATED ON (B)(6) 2010 (SEE (B)(4). INDICATION: POST IMPLANTATION PATIENT FELL AND NEVER FULLY RECOVERED. HINT OF STEM LOOSENING. STEM REPLACEMENT DECIDED. DIAGNOSIS: ASEPTIC STEM LOOSENING PROCEDURE: REVISION OF FEMORAL STEM. USING THE EXTRACTION INSTRUMENT, THE STEM CANNOT BE EXPLANTED AT FIRST. STEM FOUND TO BE DISTALLY WELL ANCHORED. THEREFORE IT IS DECIDED TO WINDOW THE BONE AND THE STEM CAN BE REMOVED SUCCESSFULLY. ONLY A FEW AMOUNT OF SYNOVITIC TISSUE DETECTED. IMPLANTATION OF THE NEW FEMORAL STEM AND HEAD AS WELL AS CERCLAGES. SECOND REVISION REPORT DATED ON (B)(6) 2019. DIAGNOSIS: INFECTION DETECTED AFTER PUNCTURE (STAPH. EPIDERMIDIS). PROCEDURE: EXPLANTATION OF TOTAL HIP PROSTHESIS. SYNOVECTOMY OF THE HIP JOINT. MULTIPLE ATTEMPTS ARE NEEDED TO REMOVE THE FEMORAL STEM. NO BONE TISSUE ATTACHED TO THE REMOVED STEM. IN THE AREA OF THE CUP A CAVE IS DETECTED WHICH SEEMS TO BE INFLAMMATED. EXPLANATION OF ALL IMPLANTS. NO COMPLICATIONS NOTED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. 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. INSTRUCTION FOR USE (IFU) FOR ALLOCLASSIC STEM, FOR THE SULOX HEAD AND FOR ALLOCLASSIC CUP STATE THAT EARLY OR LATE INFECTIONS ARE POSSIBLE SIDE EFFECTS AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. MOREOVER, THEY LIST GENERAL INSTRUCTIONS, RISK FACTORS, STERILIZATION INSTRUCTIONS, STORAGE AND HANDLING INSTRUCTIONS. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A TOTAL HIP PROSTHESIS ON (B)(6) 2009. FEMORAL COMPONENTS WERE REVISED ON (B)(6) 2010 (SEE (B)(4). THE SECOND REVISION OF ALL IMPLANTS TOOK PLACE ON (B)(6) 2019 DUE TO INFECTION (ASPIRATION POS. FOR STAPH EPIDERMIDIS). MOREOVER, A BONE SCAN PERFORMED ON (B)(6) 2018 INDICATED LOOSENING OF CUP AND STEM. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION FOR THE KNOWN LOT NUMBERS. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THE GAMMA AND ETO STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATES OF THE AFFECTED LOTS HAVE BEEN REVIEWED AND WERE FOUND TO BE ACCORDING TO SPECIFICATION. MOREOVER, NO TREND ON INFECTION HAS BEEN OBSERVED FOR THESE PART OR LOT NUMBERS. THEREFORE, IT IS HIGHLY UNLIKELY THAT A DISADVANTAGEOUS PRODUCT DESIGN OR PROCESSING FAVORED OR CONTRIBUTED TO THE INFECTION. AS THE INFECTION HAS OCCURRED AFTER MORE THAN 8 YEARS IN VIVO, A CONTRIBUTION OF THE IMPLANTS IS HIGHLY UNLIKELY. HOWEVER, THE IFUS FOR THE IMPLANTED DEVICES STATE THAT EARLY OR LATE INFECTIONS ARE POSSIBLE SIDE EFFECTS AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. NEVERTHELESS, AN INFECTION CAN HAVE NUMEROUS ROOT CAUSES. POSSIBLE CAUSES OF INFECTION INCLUDE WRONG HANDLING OF DEVICE DUE TO WRONG INFORMATION, WRONG RE-STERILIZATION PROCEDURES FOR STERILE DELIVERED PARTS OR PACKAGING FAILURE DURING TRANSPORTATION. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THE REPORTED INFECTION. 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

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS AND THERAPY DATE DETAIL OF PRODUCT: ITEM # 00000002885, ITEM NAME ALLOCL SLL REVISION STEM 5 14, LOT # 2553313. ITEM # 0100126658, ITEM NAME DURASUL ALLOCLASSIC, CSF INSERT, 58/32, LOT / SOFTWARE RELEASE # 2474598. ITEM # 00000003534, ITEM NAME ALLOCLASSIC CSF ANCHORAGE CAP 58, LOT # 2484894. THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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 PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION FOLLOWING IMPLANTATION ON THE LEFT SID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972003 SULOX, HEAD, S, 32/-3.5, TAPER 12/14 N/A LZO ZIMMER GMBH N/A 2566288

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R