BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL TAPER LINER MM/40

    MDR report key: 8925867 · Received August 23, 2019

    Report

    Report Number
    0009613350-2019-00527
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    February 11, 2019
    Report Date
    June 24, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    K091973
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. EVENT SUMMARY: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY ON (B)(6) 2007. THE PATIENT WAS SUBSEQUENTLY REVISED ON (B)(6) 2010 DUE TO INCREASED PAIN, DIFFICULTY AMBULATING, LOOSENING OF THE CUP AND A LARGE BURSAL SAC COMMUNICATING WITH THE JOINT. SOON AFTER THE REVISION, THE PATIENT REPORTED CONTINUOUS DRAINAGE AND TENDERNESS FROM THE SURGICAL SITE. THE PATIENT UNDERWENT AN INCISION AND DRAINAGE OF THE SURGICAL WOUND ON (B)(6) 2010. AFTER ALMOST 9 YEARS, THE PATIENT UNDERWENT A SECOND REVISION SURGERY ON (B)(6) 2019 DUE TO PAIN, WEAKNESS AND ELEVATED METAL IONS. REVIEW OF RECEIVED DATA: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING FINDINGS: (B)(6) 2010; REVISION OF LEFT THA SHOWED LOOSENING OF CUP AND A LARGE TROCHANTERIC BURSAL SAC COMMUNICATING WITH THE JOINT. (B)(6) 2010; FOLLOW UP VISIT ¿ HE HAS BEEN DRESSING HIS INCISION AND CHANGING DRESSING PRN. HIS INCISION HAS NEVER STOPPED DRAINING SINCE DISCHARGE. NO AREA OF DEHISCENCE, A LOT OF SWELLING DISTALLY AT THE INCISION. TENDERNESS OVER DISTAL INCISION. THERE IS MINIMAL ACTIVE DRAINAGE FROM THE STAPLE HOLES DISTALLY¿UNABLE TO EXPRESS ANY DRAINAGE/PURULENCE FROM DISTAL INCISION WITH COMPRESSION. (B)(6) 2010; IRRIGATION AND DEBRIDEMENT WITH INTRAOPERATIVE CULTURES AND REVISION CLOSURE SMALL SUPERFICIAL DEFECT NOTED WITH 50-100CC BLOOD-TINGED SYNOVIAL FLUID, TISSUES APPEARED BENIGN, NO SIGN OF PUS/PURULENCE, LIQUEFIED HEMATOMA NOTED WITHIN THE DERMAL LAYER, TISSUES DEBRIDED, WOUND CLOSED WITHOUT COMPLICATION. EBL 200ML, PRE/POSTOP DIAGNOSIS: INFECTED LEFT THA, MINIMAL AMOUNT OF TISSUE NECROSIS. NO GROWTH / SIGNIFICANT FINDINGS ON GRAM STAIN OR INTRAOP CULTURE AFTER 3 DAYS. (B)(6) 2010; PICC LINE PLACED PER INFECTIOUS DISEASE ORDERS FOR ANTIBIOTIC THERAPY FOR MRSA. (B)(6) 2010; FOLLOW UP S/P I&D ¿ NO ISSUES WITH PAIN, DRAINAGE HAS DECREASED SIGNIFICANTLY SINCE D/C. (B)(6) 2010; FOLLOW UP ¿ MILD HIP PAIN, NO LONGER TAKING PAIN MEDS, NO WALKING AIDS, VERY MINIMAL DRAINAGE. (B)(6) 2018; PROGRESS NOTE - PATIENT HAD 4 DISLOCATIONS WITHIN PAST 4-5 MONTHS, X-RAYS FROM (B)(6) 2018 SHOW NO OBVIOUS EVIDENCE OF COMPLICATIONS, LAB RESULTS FOR COBALT FOUND ABNORMAL (LAB RESULTS NOT STATED). (B)(6) 2019; IMMEDIATE POSTOP X-RAY REPORT CONFIRMS PATIENT IS STATUS POST IRRIGATION AND DRAINAGE OF A SEROMA¿POSTSURGICAL CHANGES FROM SOFT TISSUE IRRIGATION AND DRAINAGE. NORMAL X-RAYS (B)(6) 2019. MEDICAL HISTORY ACCORDING TO MEDICAL RECORDS: OBESITY, ASTHMA, HTN, ED, MIGRAINES, PTSD, PREDIABETES, DEPRESSION, OSA, CHRONIC KIDNEY DISEASE STAGE 3, HEART MURMUR, STROKE WITH HEMIPARESIS/HEMIPLEGIA, VITAMIN B12 DEFICIENCY, MULTIPLE FOOT SURGERIES WITH I&DS, FORMER SMOKER THE FOLLOWING X-RAY ANALYSIS HAS BEEN PERFORMED BY A HEALTH CARE PROFESSIONAL (HCP): THE X-RAY OF THE LEFT HIP (PELVIC OVERVIEW) DATED MARCH 09, 2010 SHOWS THE SITUATION AFTER IMPLANTATION OF A CEMENTLESS TOTAL HIP ARTHROPLASTY WITH AN OBLIQUE POSITION OF THE PELVIS AND A CUP INCLINATION ANGLE OF APPROX. 52 DEGREES. THE RADIOLOGIC FOLLOW-UP THE NEXT DAY IN AP AND LAUENSTEIN VIEW SHOWS A SLIGHT VARUS POSITION OF THE STEM (APPROX. 4 DEGREES). NO SIGNIFICANT CHANGES WERE FOUND IN THE RADIOLOGICAL FOLLOW-UP TWO MONTHS LATER ON (B)(6) 2010. THE RADIOLOGICAL FOLLOW-UP ON (B)(6) 2019, SHOWS NO SIGNIFICANT CHANGE OF THE CUP INCLINATION ANGLE (APPROX. 52 TO 53 DEGREES) WITHOUT OBVIOUS CHANGES OF BONY STRUCTURES AROUND THE IMPLANT COMPONENTS. THE RADIOLOGICAL DOCUMENTATION OF (B)(6) 2019 (PELVIC OVERVIEW, LAUENSTEIN VIEW) SHOWS THE SITUATION AFTER CUP REPLACEMENT WITH IMPLANTATION OF A CEMENTLESS CUP, FIXED WITH 5 SCREWS AND AN INCLINATION ANGLE OF APPROX. 40 DEGREES. THE RADIOLOGICAL FOLLOW-UP OF (B)(6) 2019 SHOWS NO SIGNIFICANT CHANGE IN STEM AND CUP POSITION. MEDICAL RECORDS SUMMARY: THE PATIENT UNDERWENT AN INTIAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 DUE TO OSTEOARTHRITIS. ZIMMER BIOMET PRODUCTS WERE IMPLANTED WITHOUT ANY COMPLICATIONS. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2010 DUE TO PAIN AND DIFFICULTY AMBULATING. THE PATIENT THEN UNDERWENT AN I & D PROCEDURE ON (B)(6) 2010 AND A REVISION PROCEDURE ON (B)(6) 2019 DUE TO ELEVATED METAL IONS, NOISE, INSTABILITY, AND DISLOCATION. FOLLOW UP VISIT DATED (B)(6) 2018 STATED THAT THE PATIENT HAD DISLOCATED 4 TIMES AND HAD HIGH ESR AND COBALT LEVELS. OPERATIVE NOTES OF THE REVISION PROCEDURE ON (B)(6) 2019 WERE NOT PROVIDED. HOWEVER, X-RAYS DATED (B)(6) 2019 CONFIRMED THAT THE REVISION OF LEFT THA HAD OCCURRED. THERE WERE NO OTHER FINDINGS RELATED TO THE REPORTED EVENT. 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 FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT 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. CONCLUSION SUMMARY: THE PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 DUE TO OSTEOARTHRITIS. ZIMMER BIOMET PRODUCTS WERE IMPLANTED WITHOUT ANY COMPLICATIONS. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2010 DUE TO PAIN, DIFFICULTY AMBULATING AND LOOSENING OF THE CUP. SUBSEQUENTLY, THE PATIENT UNDERWENT AN I & D PROCEDURE ON (B)(6) 2010 DUE TO POSTOPERATIVE WOUND INFECTION. FOLLOW UP VISIT DATED (B)(6) 2018 STATED THAT THE PATIENT HAD DISLOCATED 4 TIMES AND HAD HIGH ESR AND COBALT LEVELS. ANOTHER REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019 DUE TO ELEVATED METAL IONS, NOISE, INSTABILITY, AND DISLOCATION. OPERATIVE NOTES OF THE REVISION PROCEDURE ON (B)(6) 2019 WERE NOT PROVIDED. HOWEVER, X-RAYS DATED (B)(6) 2019 CONFIRMED THAT THE REVISION OF LEFT THA HAD OCCURRED. BASED ON THE RECEIVED MEDICAL RECORDS THE REPORTED EVENT CAN BE CONFIRMED. NEVERTHELESS, THE SURGICAL REPORT OF THE REVISION SURGERY PERFORMED ON (B)(6) 2019 AND LAB REPORTS ATTESTING HIGH METAL ION LEVELS HAVE NOT BEEN PROVIDED, THEREFORE REVIEW OF THESE DOCUMENTS WAS NOT POSSIBLE. FURTHER, THE PATIENT HAS A LONG MEDICAL HISTORY OF MULTIPLE COMORBIDITIES INCLUDING OBESITY, PREDIABETES, DEPRESSION, CHRONIC KIDNEY DISEASE, HEART MURMUR, STROKE WITH HEMIPARESIS/HEMIPLEGIA, VITAMIN B12 DEFICIENCY, AND MULTIPLE FOOT SURGERIES WITH I&DS. NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE QUALITY RECORDS OF THE METASUL TAPER LINER AND THE METASUL HEAD SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). IN CONCLUSION, BASED ON THE AVAILABLE INFORMATION, WE WERE NOT ABLE TO IDENTIFY AN EXACT ROOT CAUSE FOR THE REPORTED EVENT LEADING TO REVISION ON (B)(6) 2019. IT IS POSSIBLE THAT THE CAUSE IS MULTIFACTORIAL CONSISTING OF DEVICE, PROCEDURE AND PATIENT RELATED FACTORS. 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

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM: METASUL HEAD 40 CATALOG #: 00-8770-040-03 LOT #: 2517878. ITEM: FEMORAL STEM PRESS-FIT CATALOG #: 00-7864-012-20 LOT #: 60581086. ITEM: SHELL WITH CLUSTER HOLES CATALOG #: 00-8757-060-01 LOT #: 61361006. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. X-RAYS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING 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. (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN, WEAKNESS AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721422 METASUL TAPER LINER MM/40 METASUL TAPER LINERS, METASUL FEMORAL HEADS KWA ZIMMER GMBH N/A 2523065

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R