BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYSPLASIA INSERT 48/28

    MDR report key: 9178748 · Received October 11, 2019

    Report

    Report Number
    0009613350-2019-00603
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    March 12, 2019
    Report Date
    October 11, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    LXH
    PMA / PMN Number
    NA
    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 · 1

    CONCOMITANT DEVICES: ANCHORAGE CAP LAMELLA 48, REF# 2271, LOT# 2056238, BIOLOX FORTE, HEAD, L, ø 28/+3.5, TAPER 12/14, REF# 12.28.07 , LOT# 2060641, CLS SPOTORNO, STEM, 135, UNCEMENTED, 9.0, TAPER 12/14, REF#29.00.39-090 , LOT# 2008525. DHR REVIEW: THE QUALITY RECORDS INDICATE THAT ALL COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TRIGGER CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: WEAR. NO LOT TRIGGER: NO SIMILAR INVESTIGATED EVENTS FOR THE SAME LOT NUMBER 2042366 HAVE BEEN FOUND. REVIEW OF EVENT DESCRIPTION: BASED ON A FOLLOW-UP EMAIL WRITTEN BY THE TREATING SURGEON, THE PATIENT RECEIVED A TEP ON THE RIGHT SIDE ON (B)(6) 2001. AFTER 17 YEARS AND 9 MONTHS IN VIVO THE CUP, LINER AND HEAD WERE REVISED ON (B)(6) 2019 DUE TO WEAR OF THE INLAY. THE CLS STEM REMAINED IMPLANTED. REVIEW OF RECEIVED DATA: AN EMAIL, WITH CLARIFICATIONS FROM THE TREATING SURGEON, HAS BEEN RECEIVED: IMPLANTATION: TEP RIGHT. IMPLANTATION DATE: (B)(6) 2001. IMPLANTED DEVICES: ANCHORAGE CUP LAMELLA 48 (REF: 2271, LOT: 2056238), BIOLOX HEAD FORTE L, 28/+3.5, 12/14 TAPER (REF: 12.28.07, LOT: 2060641), STÜHMER DYSPLASIA INSERT 48/28 (REF: 2221, LOT: 2042366) AND CLS STEM 9 (REF: 29.00.39-090, LOT: 2008525). REVISION: REVISION DUE TO WEAR OF INLAY. REVISION DATE: (B)(6) 2019. EXPLANTED DEVICES: ANCHORAGE CUP LAMELLA 48 (REF: 2271, LOT: 2056238), BIOLOX HEAD FORTE L, 28/+3.5, 12/14 TAPER (REF: 12.28.07, LOT: 2060641) AND DYSPLASIA INSERT 48/28 (REF: 2221, LOT: 2042366) IMPLANTED DEVICES: BURCH-SCHNEIDER CUP RIGHT 50 (REF: 01.00191.250, LOT: UNKNOWN), LOW PROFIL CUP PE (REF: 63.32.46, LOT: UNKNOWN), STAREX SCREW 35 MM AND 45 MM (REF/LOT: UNKNOWN), BIOBALL DELTA CERAMIC HEAD 32 (COMPETITOR PRODUCT REF/LOT: 7011308141/01) AND BIOBALL ADAPTER 12/14 4XL (COMPETITOR PRODUCT REF/LOT: MS1811232). THE EXPLANTS ARE STORED AT THE HOSPITAL (B)(6). SURGICAL REPORTS, OF THE IMPLANTATION AND THE REVISION SURGERY, WERE NOT PROVIDED. DEVICES ANALYSIS: THE PRODUCTS ARE STORED AT THE HOSPITAL SITE. THE PRODUCTS HAVE BEEN REQUESTED BUT WERE NOT PROVIDED FOR INVESTIGATION. REVIEW OF PRODUCT DOCUMENTATION: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION (LAMELLA CUP 48, LAMELLA PE INSERT 48/28, BIOLOX FORTE HEAD 28 AND CLS STEM 9) WAS APPROVED BY ZIMMER BIOMET. THE MANUFACTURING DOCUMENTATION INCLUDING THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND FOUND TO BE ACCORDING TO SPECIFICATION. DUE TO THE MISSING SURGICAL REPORTS, THE SURGICAL TECHNIQUE COULD NOT BE COMPARED WITH THE SURGICAL APPROACH PERFORMED. CONCLUSION SUMMARY: BASED ON A FOLLOW-UP EMAIL WRITTEN BY THE TREATING SURGEON, THE PATIENT RECEIVED A TEP ON THE RIGHT SIDE ON (B)(6) 2001. AFTER 17 YEARS AND 9 MONTHS IN VIVO THE CUP, LINER AND HEAD WERE REVISED ON (B)(6) 2019 DUE TO WEAR OF THE INLAY. THE CLS STEM REMAINED IMPLANTED. A BURCH-SCHNEIDER CUP WITH A LOW PROFIL CUP, TWO SCREWS AND A BIOBALL SYSTEM, ADAPTER AND HEAD FROM MERETE (COMPETITOR PRODUCTS), WERE IMPLANTED. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE DEVICE COMBINATION IMPLANTED ON (B)(6) 2001 WAS APPROVED BY ZIMMER BIOMET. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE INVESTIGATION RESULT DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE LITTLE INFORMATION GIVEN, IT CAN ONLY BE ASSUMED THAT THE LINER HAD A PROGRESSIVE LOSS OF MATERIAL DUE TO RELATIVE MOTION BETWEEN THE CONTACT SURFACES OVER THE TIME IN VIVO OF ALMOST 18 YEARS. 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DUE TO INLAY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972124 DYSPLASIA INSERT 48/28 DYSPLASIA INSERT LXH ZIMMER GMBH N/A 2042366

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R