BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL, ALPHA INSERT, LL/36

    MDR report key: 8559822 · Received April 29, 2019

    Report

    Report Number
    0009613350-2019-00263
    Event Type
    Injury
    Date Received
    April 29, 2019
    Date of Event
    March 29, 2019
    Report Date
    September 19, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    SEE H10
    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: REVISION DUE TO DISLOCATION EVENT DESCRIPTION: IT WAS REPORTED THAT PATIENT HAD A THR SURGERY ON (B)(6) 2019. ON (B)(6) 2019, PATIENT STOOD-UP FROM HAVING BREAKFAST AND HEARD A NOISE. SINCE THEN HE NOTICED AUGMENTING NOISE WHEN MOVING THE JOINT. IN THE CLINIC EVIDENCE OF INLAY DISLOCATION SEEN ON X-RAYS. THE ASSOCIATED PRODUCT (ALLOCLASSIC SHL 58/LL) WAS FIXED. THEREFORE AN EXPLANTATION AND EXCHANGE OF THE LOOSE INLAY WAS DONE ON(B)(6) 2019 THE SHELL WAS LEFT IN THE PATIENT BECAUSE IT WASN'T LOOSENED AND THEREFORE ONLY THE INLAY WAS AVAILABLE FOR INVESTIGATION. REVIEW OF RECEIVED DATA: - PRIMARY SURGERY NOTES DATED (B)(6) 2019: INDICATION: IMMOBILIZED PAINFUL LEFT HIP JOINT. CONSERVATIVE THERAPY TO APPLY THERAPY: IMPLANTATION OF A ENDOPROSTHESIS LEFT HIP REPORT IS REVIEWED. NO ABNORMALITIES NOTICED. - REVISION SURGERY NOTES DATED (B)(6) 2019 INDICATION : SINCE THE MORNING OF 22.3 SQUEAKY NOISES FROM LEFT HIP JOINT AFTER GETTING UP FROM THE BREAKFAST TABLE. DISLOCATION, CLOSED REDUCTION WITHOUT SUCCESS, THUS DECISION TO A FURTHER REDUCTION ATTEMPT UNDER ANESTHESIA, POSSIBLY OPEN REVISION. THERAPY: REIVISON, LEFT HIP WITH HEAD/INLAY CHANGE REPORT IS REVIEWED. NO ABNORMALITIES NOTICED. DEVICE ANALYSIS: - VISUAL EXAMINATION: FOR THE INVESTIGATION ONLY THE INSERT WAS RECEIVED. THE INLAY SHOWS A HEAVILY DEFORMED PEG AND DISTINCT SCRATCHES ON BOTH THE ANCHORING AND ARTICULATING SURFACES. PARALLEL SCRATCHES TAKING PLACE ON THE ANCHORING AREA OF THE INLAY HINT TO THE FACT THAT THE INLAY WAS DISLOCATED AND WAS STILL INSIDE THE ACETABULAR SOCKET FOR SOME TIME. THE SCRATCHES LOCATED ON THE RIM REFER TO DEFORMATIONS MOST PROBABLY OCCURRED DURING THE REVISION SURGERY. ON THE ANCHORING SURFACE OF THE INLAY 2 IMPRINTS FROM THE SPIKES OF THE METALLIC SHELL CAN BE DETECTED. IMPRINTS SEEM TO BE IN SAME DISTANCE FROM THE POLAR PEG INDICATING A CORRECT ALIGNMENT OF THE INLAY WITHIN THE SHELL. HOWEVER, THOSE IMPRINTS SEEM VERY SHALLOW AND NOT DEEP. ADDITIONALLY, THERE ARE SCRATCHES ON THE ARTICULATING SURFACE OF THE INLAY, WHICH COULD HAVE HAPPENED AFTER THE INLAY WAS DISLOCATED IN THE CUP. BASED ON THIS VISUAL EXAMINATION THE REPORTED EVENT CAN BE CONFIRMED. 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 , PAGES 11 AND 12: LINER INSERTION THE POLE PLUG ALLOWS APPROPRIATE FITTING WITH THE POLYETHYLENE LINER PEG. BONE OR SOFT TISSUE REMNANTS MUST NOT OVERLAP THE EDGE OF THE TITANIUM SHELL AS THEY MAY PREVENT THE INSERT FROM SNAPPING INTO POSITION. THE SHELL EDGE MUST BE FREE FROM ANY TISSUE AND PARTICULAR ATTENTION MUST BE PAID TO THE POSTERIOR INFERIOR BONY EDGE OF THE ACETABULUM. CLEAN AND DRY THE INNER SURFACE OF THE SHELL, CONNECT THE LINER TO THE SETTING INSTRUMENT, POSITION THE LINER OVER THE ENTRANCE PLANE OF THE SHELL AND ROTATE CLOCKWISE. THE PEG OF THE POLYETHYLENE LINER MUST BE INSERTED INTO THE POLE PLUG HOLE (FIGURES 15 AND 16). COMPLETE SEATING OF THE LINER WITH A LIGHT HAMMER BLOW. IF THE LINER CAN STILL BE ROTATED AFTER LIGHT IMPACTION, THIS INDICATES MISPOSITIONING, NONCONCENTRIC, OR SOFT TISSUES INTERFERENCE BETWEEN THE LINER AND THE SHELL SURFACES. CONCLUSION: REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PRODUCT DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED EVENT. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). VISUAL EXAMINATION OF THE RECEIVED INSERT SHOWED THAT THE INSERT WAS NOT FIXED WELL INSIDE METAL SHELL. SHALLOW IMPRINTS FROM THE METAL SPIKES CONFIRM THAT IMPACTION FORCE APPLIED ON THE INSERT WAS INSUFFICIENT. THEREFORE, INSERT GOT LOOSE AFTER SOMETIME IN-VIVO AND RESULTED IN DISLOCATION. BASED ON THE RETURNED PRODUCT AND THE GIVEN INFORMATION THE COMPLAINT COULD BE CONFIRMED. THE ROOT CAUSE IS IDENTIFIED AS USER ERROR. 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 0009613350-2019-00263.

    Additional Manufacturer Narrative · 1

    INFORMATION: THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WINTERTHUR AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K993259. CONCOMITANT MEDICAL PRODUCTS: ALLOFIT ALLOCLASSIC SHELL 58/LL, ITEM # 4248, LOT: 2972430; UNKNOWN HEAD ITEM # UNKNOWN; LOT: UNKNOWN. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. SURGICAL REPORTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 A PATIENT UNDERWENT A REVISION SURGERY DUE TO DISLOCATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353281 DURASUL, ALPHA INSERT, LL/36 N/A JDI ZIMMER GMBH N/A 2973010

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R