BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN METASUL HIP INSERT

    MDR report key: 6933712 · Received October 10, 2017

    Report

    Report Number
    0009613350-2017-01411
    Event Type
    Injury
    Date Received
    October 10, 2017
    Report Date
    January 29, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFORE TRIED SEVERAL TIMES TO RECEIVE ADDITIONAL INFORMATION FOR THIS CASE. THE MISSING INFORMATION WAS REQUESTED AT COMPLAINANT THE LATEST ONE ON OCTOBER 07, 2017 BUT WAS NOT AVAILABLE. REVIEW OF DEVICE HISTORY RECORDS: THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. TREND ANALYSIS: NO TREND ANALYSIS COULD BE PERFORMED AS NO ITEM NUMBER(S) IS/ARE AVAILABLE. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT HAD INITIALLY UNDERGONE A THA IN 2011 (ASSUMED DATE IS (B)(6) 2011), WHERE ALLOFIT CUP 60MM AND METASUL LINER WERE IMPLANTED. PATIENT UNDERWENT THE FIRST REVISION OF THE THA ON (B)(6) 2017 DUE TO UNKNOWN REASONS, WHERE THE LINER AND HEAD WERE REPLACED WITH DURASUL LINER (REF:01.00013.713 LOT:2838483) AND COCR HEAD (REF:01.01012.366 LOT:2879338). LATER ON, PATIENT HAD A WASH OUT SURGERY ON (B)(6) 2017 DUE TO UNKNOWN REASONS, WHERE THE PRODUCTS REMAINED IN-SITU. SUBSEQUENTLY, PATIENT UNDERWENT A SECOND REVISION SURGERY ON (B)(6) 2017 DUE TO INFECTION, WHERE THE LINER AND HEAD WERE REPLACED WITH DURASUL LINER (REF: 01.00013.713 LOT: 2835104) AND COCR 36MM HEAD (REF: 01.01012.366 LOT 2882093). THIS COMPLAINT COVERS THE EVENT OF 1ST REVISION DUE TO UNKNOWN REASONS ON (B)(6) 2017. (B)(4) - WASHOUT SURGERY ON (B)(6) 2017. (B)(4) - 2ND REVISION DUE TO INFECTION ON (B)(6) 2017. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WAS NOT AVAILABLE. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. IT WAS REPORTED THAT PRODUCT LOCATION IS UNKNOWN. REVIEW OF PRODUCT DOCUMENTATION: NO PRODUCT DOCUMENTATION WAS REVIEWED FOR INVESTIGATION SINCE NO PRODUCT IDENTIFICATION WAS POSSIBLE. ROOT CAUSE ANALYSIS: NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, OR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. CONCLUSION SUMMARY: ACCORDING TO THE REPORTED EVENT HEAD AND LINER OF THE THA WERE REVISED DUE TO UNKNOWN REASONS AFTER 6 YEARS 8 MONTHS IN-VIVO TIME. NO MEDICAL DOCUMENTS WERE RECEIVED CONFIRMING ANY EVENT. NO REF/LOT NUMBERS OF THE PRODUCTS INVOLVED WERE AVAILABLE FOR THE INVESTIGATION. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL INVESTIGATION OF THE REPORTED EVENT. SHOULD ANY ADDITIONAL INFORMATION THAT CHANGES THE ASSESSMENT BECOME AVAILABLE, THE CASE WILL BE RE-EVALUATED. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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). THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED IN 2011 WITH A ALLOFIT CUP 60MM AND METASUL LINER ON AN UNKNOWN SIDE. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO UNKNOWN REASON AND THE METASUL LINER WAS REVISED. AS EXACT IMPLANTATION DATE IS UNKNOWN THE LAST DAY OF THE YEAR REPORTED IS TAKEN IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717366 UNKNOWN METASUL HIP INSERT KWA ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN ZIMMER HEAD CATALOG #: UNKN. LOT #: UNKN.