BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL®, ALPHA INSERT, MM/36

    MDR report key: 13730954 · Received March 11, 2022

    Report

    Report Number
    0009613350-2022-00139
    Event Type
    Injury
    Date Received
    March 11, 2022
    Date of Event
    May 29, 2019
    Report Date
    June 6, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(6) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. CONCOMITANT MEDICAL PRODUCT: COCR HEAD, M, 36/0, TAPER 12/14, CATALOG#: 01.01012.366; LOT#: 2670830. DUE TO FACT THAT THIS IS A LEGAL CLAIM, OUR LEGAL DEPARTMENT HAS BEEN PROVIDED WITH THE AVAILABLE FACTS FROM THE CUSTOMER. ZIMMER GMBH (B)(6) LEGAL DEPARTMENT IS WELL TRAINED AND PASSES ALL INFORMATION CONCERNING THE CASE TO OUR COMPLAINT HANDLING DEPARTMENT. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2022-00140.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6), 2013, WHEREBY A COCR HEAD AND DURASUL INLAY WERE IMPLANTED IN THE RIGHT HIP. THE PATIENT UNDERWENT REVISION SURGERY OF THE UNKNOWN CUP ON (B)(6), 2019 DUE TO PERIPROSTHETIC OSTEOLYSIS AND METALLOSIS. REVIEW OF RECEIVED DATA: DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. THE IMPLANT LABELS OF THE IMPLANTED PRODUCTS ON (B)(6), 2013 HAVE BEEN PROVIDED. FORENSIC OPINION REPORT FROM DR. (B)(6) (LEGAL DOCTOR) RECEIVED DATED NOV 22, 2021. THE FOLLOWING MEDICAL PROCEDURES ARE MENTIONED IN THE LEGAL REPORT. PLEASE NOTE, THE REPORT WAS TRANSLATED FROM ITALIAN TO ENGLISH AND SUMMARIZED: PATIENT UNDERWENT LEFT HIP ARTHROPLASTY IN 1997 AND REVISION OF THE CUP IN THE SAME YEAR PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY IN 2004 PATIENT UNDERWENT REVISION SURGERY OF THE LEFT HIP IN 2005 PATIENT ADMITTED FROM (B)(6), 2013 TO (B)(6), 2013 DUE TO DIAGNOSIS DEFINED AS FRACTURE OF PROSTHETIC COMPONENT OF RIGHT HIP AP, WEAR OF RIGHT AND LEFT HIP PATIENT UNDERWENT REVISION SURGERY ON (B)(6), 2013 DUE TO FRACTURE OF BOTH THE CERAMIC HEAD AND CERAMIC INSERT. DUE TO THE PRESENCE OF OSTEOLYSIS AROUND THE SUPRA-ACETABULAR AREA, THE STABILITY OF THE CUP IS ASSESSED WITHOUT NOTING OF ANY LOOSENING. PATIENT WAS EXAMINED ON (B)(6) 2019 AND HAS BEEN EXPERIENCING ACUTE PAIN IN THE RIGHT THIGH FOR ABOUT 8 DAYS. A CT SCAN OF THE PELVIS PERFORMED SHOWS EXTENSIVE PERIACETABULAR BONE OSTEOLYSIS ON THE RIGHT AND NEOFORMATION OF TISSUE THAT EXPANDS FROM THE BONE INTO THE PERIACETABULAR TISSUE. SUGERY PERFORMED ON (B)(6), 2019 DETECTED THE PRESENCE OF APPEARANCE OF METALLOSIS (PRESENCE OF ABUNDANT DARK LIQUID AND FORMATION OF THICKENED PSEUDOCAPSULE; PRESENCE OF DARK INFILTRATES/DEBRIS IN THE SEAT OF THE CUP; LYSIS MASSIVE BOTH CRANIAL AND AT THE LEVEL OF THE ISCHIUM AND ILEOPUBIC. THE FEMORAL HEAD SHOWS NO MACROSCOPIC DAMAGES. THE AVAILABLE AUGMENTS ARE NOT WELL SUITED FOR THE BONE DEFECTS, SO BONE FROM THE BANK IS USED. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION WITH NO NCR WITH A POTENTIAL CORRELATION TO THE REPORTED EVENT WAS FOUND. REVIEW OF COMPLAINT HISTORY IDENTIFIED NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION RELATED TO THE EVENT. CONCLUSION: IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6), 2013, WHEREBY A COCR HEAD AND DURASUL INLAY WERE IMPLANTED IN THE RIGHT HIP. THE PATIENT UNDERWENT REVISION SURGERY OF THE UNKNOWN CUP ON (B)(6), 2019 DUE TO PERIPROSTHETIC OSTEOLYSIS AND METALLOSIS. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. PATIENT OR SURGICAL FACTORS THAT MAY HAVE AFFECTED THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), INCLINATION ANGLE OF THE IMPLANTED PRODUCTS AND THE PRODUCT IDENTIFICATION OF ALL THE ADDITIONAL INVOLVED PRODUCTS ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. DUE TO THE ARTICULATION PAIRING OF THE INLAY (POLYETHYLENE) AND HEAD (COCR) METALLOSIS IS NOT POSSIBLE. A POSSIBILITY OF METALLOSIS COULD BE DUE TO DIRECT CONTACT BETWEEN THE HEAD AND CUP OR MICROMOTION BETWEEN THE HEAD AND THE STEM. HOWEVER, AS THE CONDITION OF THE INLAY AND THE TYPE OF STEM USED ARE UNKNOWN, NO POSSIBLE LINKS CAN BE MADE. PERIPROSTHETIC OSTEOLYSIS OF THE CUP HAS BEEN REPORTED, WHEREBY THE CUP WAS REVISED. HOWEVER, THE CONDITION OF THE INLAY AND LEVEL OF POSSIBLE WEAR ARE UNKNOWN. ADDITIONALLY, NO X-RAYS HAVE BEEN PROVIDED WHICH SHOW THE INCLINATION ANGLE OF THE INLAY. BASED ON THE RECEIVED FORENSIC OPINION REPORT THE REPORTED EVENT CAN BE CONFIRMED. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    CLAIM FOR DAMAGES ALLEGEDLY CAUSED BY COCR HEAD AND DURASUL INSERT. IT WAS REPORTED THAT THE PATIENT HAD A REVISION PROCEDURE, OUTCOME REVISION DUE TO METALLOSIS.

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220496 DURASUL®, ALPHA INSERT, MM/36 HIP PROSTHESIS KWA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2495148

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L SEE H10 NARRATIVE