BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTASUL®, S30 HEAD, S, 28/-4, TAPER 12/14

    MDR report key: 7376558 · Received March 28, 2018

    Report

    Report Number
    0009613350-2018-00385
    Event Type
    Injury
    Date Received
    March 28, 2018
    Date of Event
    February 14, 2018
    Report Date
    July 2, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PNA
    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

    DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: REVISION DUE TO DISLOCATION. EVENT SUMMARY: IT IS REPORTED THAT A PATIENT RECEIVED ZIMMER IMPLANTS (ADES DUAL MOBILITY, PROTASUL S30 HEAD AND AVENIR STEM) ON (B)(6) 2018 AND UNDERWENT A REVISION ON (B)(6) 2018 DUE TO SEPARATION OF THE ADES DEVICE FROM THE HEAD. REVIEW OF RECEIVED DATA: UNDATED X-RAY, RIGHT HIP WITH FEMUR AP-PROJECTION: PROBABLY DATING PRIOR TO OP ON (B)(6) 2018 GIRDLESTONE-SITUATION WITHOUT AN IMPLANT IN BONE DEFECT SITUATION WITH A LACK OF THE PROXIMAL FEMUR AND MASSIVE PERIARTICULAR OSSIFICATIONS. X-RAY DATED (B)(6) 2018, RIGHT HIP WITH FEMUR AP-PROJECTION: CEMENTED STEM IN CORRECT POSITION, AROUND THE PROXIMAL STEM TWO CERCLAGE WIRE INTACT. BONY DEFECT SITUATION WITH MISSING PROXIMAL FEMUR. IN THIS PROJECTION, THE INCLINATION ANGLE OF THE CUP CAN NOT BE ASSESSED ACCURATELY, BUT IT DOES NOT APPEAR TOO STEEP. BASED ON THIS SINGLE PROJECTION LEVEL A MISMATCH BETWEEN FEMORAL HEAD AND CUP CAN NOT BE ASSESSED WITH CERTAINTY. X-RAY DATED (B)(6) 2018, RIGHT HIP WITH FEMUR AP-PROJECTION: CEMENTED STEM IN CORRECT POSITION, AROUND THE PROXIMAL STEM TWO CERCLAGE WIRE INTACT. BONY DEFECT SITUATION WITH MISSING PROXIMAL FEMUR. COMPARED TO THE PREVIEW OF (B)(6) 2018 THE FEMORAL HEAD IS DECENTERED IN THE CUP. IN THIS PROJECTION, THE INCLINATION ANGLE OF THE CUP CAN NOT BE ASSESSED ACCURATELY, BUT IT DOES NOT APPEAR TOO STEEP. IN PROJECTION ON THE SOFT TISSUES LOCATED LATERALLY OF THE HIP, RECOGNIZABLE ROUNDISH LIGHTENING AS A POSSIBLE INDICATION OF A FOREIGN BODY, PROBABLY THE INSERT WHICH IS DISLOCATED FROM THE CUP. UNDATED X-RAY, RIGHT HIP WITH FEMUR AP-PROJECTION: SITUATION WITH DISLOCATED TOTAL HIP ENDOPROSTHESIS, STEM AND CUP WITHOUT SIGNS OF LOOSENING. PROBABLY TAKEN AFTER THE REVISION SURGERY ON (B)(6) 2018. SURGICAL REPORT DATED (B)(6) 2018: INDICATION: THE PATIENT HAD A GIRDLESTONE SITUATION AFTER REMOVAL OF THA COMPONENTS PROBABLY DUE TO INFECTION ABROAD. NOW LOW INFECTIOUS PARAMETERS, SONOGRAPHICALLY NO INDICATION OF A BEHAVIOR AND AFTER DETAILED MULTIPLE EDUCATION OF THE PATIENT ABOUT COMPLICATION POSSIBILITIES INDICATION TO THE REPLACEMENT. OPERATION: IT SHOWS, THAT THE PROXIMAL FEMUR IS LARGELY ABSENT, IS ALSO NOT VISIBLE DUE TO MASSIVE CALCIFICATION VENTRAL DORSAL AND REACHING TO THE ILIAC CREST. OSSIFICATION ARE REMOVED AND SENT FOR HISTOLOGY. REMOVAL OF HETEROTOPIC OSSIFICATIONS IN THE SOCKET AREA. THE SOCKET IS OVERALL A BIT SOFT AND OSTEOPOROSIS. CEMENTING AN ADES OF SIZE 50 MM. GRADUALLY RASPING THE FEMUR UP TO SIZE 4. THEN THE TRIAL WITH THE SHORT HEAD, THIS DOES NOT SUCCEED. CHANGE TO THE SIZE 3, THEN TO THE SIZE 2. WITH THE SIZE 2, THE TRIAL REDUCTION SUCCEEDS. AFTER THE TRIAL REDUCTION, DISLOCATION OF THE CUP OCCURS DURING REDUCTION. THE CEMENT IS REMOVED WITH THE CHISEL AND THE BOTTOM OF THE ACETABULUM DEEPENED WITH THE CUTTER, THEN SHELL IS CEMENTED AGAIN. AFTER WAITING FOR CURING THEN PROCEEDING TO THE FEMUR. INSERTION OF THE MEDULLARY BARRIER SIZE 3.5 WEBER STÜHMER IN THE CORRECT DEPTH. JET LAVAGE AND CEMENT THE LATERALIZED PROSTHESIS SIZE 2 TO THE CORRECT DEPTH IN THE CORRECT ANTEVERSION. WAITING FOR THE CURING. REMOVING THE EXCESS CEMENT, DRYING AND CLEANING THE CONE. PLACEMENT OF THE TRIAL, STABLE CONDITIONS ACHIEVED. THEN PLACING THE FINAL COMPONENT AFTER CLEANING AND DRYING THE CONE AND REPOSITIONING STABLE CONDITIONS. THE PROXIMAL FEMUR AND APPROACH OF THE GLUTEUS MEDIUS WAS PREVIOUSLY NON-EXISTENT AND EXTERNAL STILL NOT. NO DISLOCATION TENDENCY OBSERVED. THE DESIRED LEG EXTENSION CAN NOT BE ACHIEVED IN FULL, DESPITE RELAXATION, IT WAS NOT POSSIBLE TO INSTALL THE PLANNED PROSTHESIS SIZE 3. SURGICAL REPORT DATED (B)(6) 2018: INDICATION: HIP DISLOCATION ON THE RIGHT WITH INLAY DISLOCATION OPERATION: THE PE INLAY, WHICH IS COMPLETELY DISLOCATED, IS RECOVERED SUBFASIALLY. THE SHORT HEAD IS STILL ON THE STEM. THE HEAD IS KNOCKED OFF FROM THE STEM. EXTENSIVE RINSING. NEW PE FOR CUP SIZE 50MM IS ATTACHED WITH A LONG HEAD AFTER CLEANING THE CONE. REDUCTION. HIP SITS STABLE. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: ZIMMER - DEDIENNE_DISTRIBUTION AGREEMENT IS REVIEWED AND CONFIRMED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA: INCREASED RELEASE OF METAL/POLYETHYLENE WEAR PARTICLES DUE TO DISLOCATION, SUBLUXATION DUE TO SOFT TISSUE LAXITY. POSSIBLE: SOFT TISSUE IS INDICATED IN THE SURGICAL REPORT IN ADDDITION TO THE LARGE BONY DEFECT WITH NO NECESSARY MUSCLE GROUPS ATTACHED TO THE MISSING PROXIMAL FEMUR TO ENSURE STABILITY. LEG LENGTH DIFFERENCE, RISK OF DISLOCATION OR REDUCED ROM, REDUCED JOINT STABILITY DUE TO WRONG SELECTION OF OFFSET BY SURGEON. POSSIBLE: DURING THE REVISION SURGERY ON (B)(6) SURGEON REPLACED THE HEAD WITH A LONGER HEAD, WHICH CONFIRMS THAT THE HEAD OFFSET SELECTION WAS NOT APPROPRIATE. INCREASED WEAR, COMPONENT LOOSENING OR FRACTURE (LEADING TO REDUCTION OF DEVICE LIFE-TIME), SUB-/LUXATION DUE TO - WRONG BEHAVIOR OF THE PATIENT: - HIGH PATIENT ACTIVITY, - PATIENT DISREGARDS LIMITS OF THE DEVICE. POSSIBLE: THE PATIENT ACTIVITY AFTER THE OP IS UNKNOWN, THEREFORE CANNOT BE EXCLUDED. INCREASED RELEASE OF PE WEAR PARTICLES, LOOSENING OF COMPONENTS, SUBLUXATION, DISLOCATION; REDUCED/LIMITED ROM DUE TO IMPINGEMENT DUE TO INCORRECT POSITION OF STEM OR CUP. POSSIBLE: THE RECEIVED X-RAYS DO NOT SHOW THE WHOLE PELVIS, WHICH MAKES IT NOT POSSIBLE TO ASSESS THE INCLINATION ANGLE OF THE CUP. HOWEVER, IT IS SEEN THAT THE INC. ANGLE IS LOW WHICH COULD LEAD TO DISLOCATION. CONCLUSION SUMMARY THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE DISLOCATION AFTER 6 DAYS IN-VIVO TIME. REVISION SURGERY REPORT AND THE X-RAYS CONFIRM THE EVENT. DURING THE REVISION SURGERY HEAD AND THE DISLOCATED INSERT WERE REVISED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PRODUCT DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED EVENT. THE REVIEW OF THE OP DATED (B)(6) 2018 SHOWS THAT IT WAS NOT POSSIBLE TO IMPLANT THE PREFERRED SIZE OF THE STEM DUE TO BONY DEFECT SITUATION AND ASSOCIATED SOFT TISSUE CONDITION, FOLLOWED BY DISLOCATION OF THE CUP DURING OPERATION WHICH REQUIRED SUBSEQUENT MILLING AND CEMENTING AFTER X-RAY REVIEW ALSO SHOWED THAT THE ACETABULAR CUP HAS A RATHER LOW INCLINATION ANGLE, BUT WITHOUT A FULL PELVIS X-RAY IT IS NOT POSSIBLE TO MAKE EXACT COMMENTS ON THE CORRECTNESS OF THE CUP POSITION. MOST POSSIBLE REASONS LEADING TO THE DISLOCATION CAN BE NAMED AS SUBLUXATION DUE TO SOFT TISSUE LAXITY, WRONG SELECTION OF OFFSET BY SURGEON AND WRONG POSITION OF CUP. WRONG BEHAVIOR OF THE PATIENT AND HIGH PATIENT WEIGHT (BMI=27.8) COULD BE ALSO OTHER FACTORS CONTRIBUTING TO THE DISLOCATION EVENT. 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 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).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ZIMMER BIOMET: AVENIR®, STEM, LATERAL, CEMENTED, 2, TAPER 12/14, ITEM#01.06010.302, LOT#2917177; DEDIENNE SANTÉ: DUAL MOBILITY ADES CMNTD 50MM, REF#(B)(4), LOT#109279160AF17; DEDIENNE SANTÉ: DUAL-MOB ADES INSERT 28MM SZ50, REF#(B)(4), LOT#109279320AF17. X-RAYS, SURGICAL REPORTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE HEAD IS NOT RECEIVED FOR INVESTIGATION, ACCORDING TO THE INFORMATION RECEIVED IT WAS DISCARDED AT THE HOSPITAL. THE STEM IS IN VIVO. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORD 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. THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E. DURASUL COCR HEAD 38/-8 XS 12/14 510K#993259) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT WAS REVISED 6 DAYS POST IMPLANTATION DUE TO DISLOCATION AND SEPARATION OF THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220314 PROTASUL®, S30 HEAD, S, 28/-4, TAPER 12/14 NA KWA ZIMMER GMBH N/A 2920176

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R