BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL HEAD 40, 12/14, SIZE M /0

    MDR report key: 8486691 · Received April 5, 2019

    Report

    Report Number
    0009613350-2019-00190
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    January 28, 2014
    Report Date
    December 10, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    K091973
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: REF: 00-8770-011-40; LOT: 2615734. YIELD: 25;DELIVERED: 25. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF: 00-8770-040-02; LOT: 2627484. YIELD: 30; DELIVERED: 30. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TRIGGER CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: PAIN / ILIOPSOAS TIGHTNESS EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT, PARTICIPATING IN THE CONTINUUM MOM STUDY, UNDERWENT A LEFT HTEP ON (B)(6) 2012 AND EXPERIENCED PAIN AND ILIOPSOAS TENDONITIS APPROX. 2 YEARS POST SURGERY. REVIEW OF RECEIVED DATA: IN TOTAL FOUR X-RAYS (TWO INTRA OPERATIVE IMAGES DATED (B)(6) 2012 AND TWO POST-OPERATIVE IMAGES DATED (B)(6) 2014) HAVE BEEN RECEIVED FOR REVIEW. THE RADIOGRAPHS WERE REVIEWED BY A HEALTH CARE PROFESSIONAL. LEFT HIP AP-VIEW, (B)(6) 2012: THE CUP IS A BIT OVERSIZED, THE IMPLANT CRANIALLY SURMOUNTS THE BONY ACETABULUM MARGIN. MISSING REFERENCE LINE FOR MEASURING THE INCLINATION ANGLE OF THE CUP. THE ANTEVERSION OF THE CUP IS NOT RADIOLOGICALLY ASSESSABLE. LEFT HIP LAUENSTEIN-VIEW, (B)(6) 2012: POSTOPERATIVE IMAGE, STAPLES ARE VISIBLE. VENTRAL SUPERIOR CUP. LEFT HIP AP-VIEW, (B)(6) 2014: COMPARED TO THE PREVIOUS X-RAY NO RELEVANT CHANGES OF THE IMPLANT POSITION. LEFT HIP LAUENSTEIN-VIEW, (B)(6) 2014: COMPARED TO THE PREVIOUS X-RAY NO RELEVANT CHANGES OF THE IMPLANT POSITION. X-RAY CONCLUSION: AN IMPINGEMENT SYNDROME OF PROSTHESIS COMPONENTS IS EXTREMELY RARE. MUCH MORE COMMON IS BONY SOFT TISSUE IMPINGEMENT, SUCH AS GREATER TROCHANTER AND ILIUM, AND BETWEEN THE ISCHIAL BONE AND THE LESSER TROCHANTER. AS A RULE, OFFSET REDUCTIONS ARE THE CAUSE OF THIS PROBLEM. HOWEVER, AN OFFSET REDUCTION CANNOT BE RECOGNIZED ON THE AVAILABLE X-RAYS. ONE OF THE MOST WELL-KNOWN MUSCULAR PAIN SYNDROMES AFTER HIP ENDOPROSTHESIS IMPLANTATION IS THE ILIOPSOAS-IMPINGEMENT, IN WHICH THERE IS A PAINFUL CONTACT BETWEEN ILIOPSOAS TENDON AND CUP EDGE. CHRONIC IRRITATION OF THE PSOAS TENDON AND BURSA ILIOPECTINEA TO A PROMINENT ANTERIOR MARGIN OF THE ACETABULUM MAY RESULT IN PAINFUL RESTRICTIONS ON THE MOVEMENT OF THE HIP JOINT, CORRESPONDING TO AN IMPINGEMENT PHENOMENON. THE TYPICAL HISTORY, PAIN IN THE POWERFUL HIP FLEXION BETWEEN 0-70° AND A POSITIVE LOCAL ANESTHETIC TEST POINTS TO THIS DIAGNOSIS. CARE SHOULD BE TAKEN DURING IMPLANTATION TO ENSURE PROPER INCLINATION AND ADEQUATE BONY COVERAGE OF THE LOWER MARGIN OF THE CUP. A VERY STEEP (LARGE) INCLINATION AND INSUFFICIENT BONY CUP COVERAGE ARE A POTENTIAL RISK FACTOR FOR MUSCLE-SOCKET CONTACT. THUS, A LARGE INCLINATION ANGLE CAN BE CONSIDERED AS A CONTRIBUTING FACTOR FOR A POSSIBLE IMPINGEMENT OF THE OBTURATOR EXTERNUS MUSCLE WITH THE ACETABULUM, HOWEVER, THE INCLINATION ANGLE CANNOT BE DETERMINED IN THE PRESENT CASE. MEDICAL RECORDS OF THE PRIMARY SURGERY DATED (B)(6) 2012 WITH LIMITED INFORMATION WAS PROVIDED AND IS SUMMARIZED BELOW. PLEASE NOTE: THE SURGICAL REPORT WAS TRANSLATED FROM FINNISH TO ENGLISH. DIAGNOSIS: PRIMARY OSTEOARTHRITIS OF BOTH HIP JOINTS, LEFT THERAPY: THE PATIENT RECEIVES A LEFT HTEP. THE NATURE OF THE PROCEDURE IS EXPLAINED TO THE PATIENT AND THE PATIENT HAS UNDERSTOOD IT. SURGICAL REPORT: TOTAL HIP REPLACEMENT, LEFT, CEMENTLESS SURGEON/STAFF: (B)(6). THE DESCRIPTION OF PROCEDURE MENTIONS A RUPTURE OF THE GLUTEUS MINIMUS OTHERWISE NO COMPLICATIONS OR ABNORMALIES. POST-OPERATIVE COURSE WITHOUT PAIN. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS, AS ALL PRODUCTS REMAIN IMPLANTED. 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. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT, PARTICIPATING IN THE CONTINUUM MOM STUDY, UNDERWENT A LEFT HTEP ON (B)(6) 2012 AND EXPERIENCED PAIN AND ILIOPSOAS TENDONITIS APPROX. 2 YEARS POST SURGERY. THE IMPLANTS REMAIN IMPLANTED, THEREFORE, A PRODUCT INVESTIGATION COULD NOT BE PERFORMED. REVIEW OF THE AVAILABLE X-RAY RECORDS COULD NOT IDENTIFY AN OSSEOUS SITUATION THAT WOULD LEAD TO THE REPORTED SYMPTOMS. THE MEDICAL RECORDS OF THE PRIMARY SURGERY WITH LIMITED INFORMATION DID NOT SHOW ANY ABNORMALIES THAT WOULD EXPLAIN THE REPORTED SYMPTOMS TWO YEARS POST-IMPLANTATION. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE DOCUMENT-BASED INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE LACK OF MEDICAL RECORDS ON THE REPORTED EVENT, THIS COMPLAINT COULD NOT BE CONFIRMED AND BASED ON THE GIVEN INFORMATION IT REMAINS UNKNOWN IF AND TO WHAT EXTENT THE REPORTED PRODUCTS WERE INVOLVED IN THE REPORTED EVENT. 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2019-00189-2.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. 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 · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: DETAILS OF PRODUCTS: ITEM # 00877001140, ITEM NAME METASUL TAPER LINER JJ/40, LOT # 2615734. ITEM # 00771100520, ITEM NAME FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 5 EXTENDED OFFSET, LOT # 61510556. ITEM # 00875705401, ITEM NAME SHELL WITH CLUSTER HOLES POROUS 54 MM O.D. SIZE JJ FOR USE WITH JJ LINERS, LOT # 61960312. THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION AS THE PATIENT HAS NOT BEEN REVISED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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 STARTED TO BE MONITORED DUE TO PAIN AND ILIOPSOAS TENDONITIS. THE PATIENT UNDERWENT PHYSIOTHERAPY AND PAIN KILLERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278913 METASUL HEAD 40, 12/14, SIZE M /0 METASUL TAPER LINERS, METASUL FEMORAL HEADS KWA ZIMMER GMBH N/A 2627484

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other