BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOFIT ALLOCLASSIC SHL 50/HH

    MDR report key: 7555861 · Received May 31, 2018

    Report

    Report Number
    0009613350-2018-00558
    Event Type
    Injury
    Date Received
    May 31, 2018
    Date of Event
    May 3, 2018
    Report Date
    December 4, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK003758
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: REF#: 4244 LOT#: 2860270. - YIELD: 50. - DELIVERED: 50. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF#: 01.00013.408 ; LOT#: 2858907 .- YIELD: 80. - DELIVERED: 80. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF#: 01.06010.004 ; LOT#: 2854242 - YIELD: 39 - DELIVERED: 37 - SCRAPPED: 2. - REASON FOR SCRAPPING: DAMAGED DURING WASHING AND EMPLOYEE ERROR THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF#: 17.32.06 ; LOT#: 2862438. - YIELD: 97 .- DELIVERED: 97. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: ALLERGIC REACTION. EVENT DESCRIPTION: THE SURGEON CONTACTED ZIMMER BIOMET, TO RECEIVE MATERIALS TESTS TO INVESTIGATE A POTENTIAL CONTACT ALLERGY OF THE PATIENT TO ONE COMPONENT OF THE HIP PROTHESIS. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS AS THE DEVICES REMAIN IMPLANTED. REVIEW OF PRODUCT DOCUMENTATION: - THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. - THE APPLICABLE (IFU) INSTRUCTION LEAFLET FOR ENDOPROTHESIS MENTIONS THAT A SUSPECTED ALLERGIC REACTION TO IMPLANT MATERIALS IS A RISK FACTOR. ALTHOUGH ALLERGIES AND OTHER REACTIONS TO IMPLANT MATERIALS ARE UNUSUAL, THEY SHOULD BE TAKEN INTO CONSIDERATION AND EXCLUDED BEFORE SURGERY. IN THE SECTION SIDE EFFECT IT IS MENTIONED THAT THE GENERAL RISKS INVOLVED IN ENDOPROSTHETICS ARE ALLERGIC REACTIONS TO THE IMPLANT MATERIAL USED AND "TISSUE REACTIONS AND ALLERGIES TO THE PRODUCTS OF CORROSION OR WEAR AND CEMENT PARTICLES. AS CONTRAINDICATIONS IS LISTED: ALLERGY TO THE IMPLANTED MATERIAL, ABOVE ALL TO METAL (E.G. COBALT, CHROMIUM, NICKEL, ETC.). CONCLUSION SUMMARY: IT IS REPORTED THAT THE PATIENT IS SUSPECTED TO HAVE A CONTACT ALLERGY ON A IMPLANT MATERIAL. AS IT IS INDICATED IN THE APPLICABLE PACKAGE INSERT (INSTRUCTION LEAFLET FOR ENDOPROSTHESES), ALLERGIES SHOULD BE TAKEN INTO CONSIDERATION AND EXCLUDED BEFORE IMPLANTATION OF THE DEVICES. IT IS A POTENTIAL RISK FACTOR OF A PROTHESIS. THE EXACT SYMPTOMS OF THE PATIENT AS WELL AS THE CONDITION OF THE IMPLANTS REMAIN UNKNOWN. INVESTIGATION OF THE CASE SHOWS THE CHAMICAL COMPOSTION OF THE IMPLANTS USED AS FOLLOWS: REF 4244 ALLOFIT CUP IS MANUFACTURED FROM PROTASUL-10 (MAINLY COBALD, CHROMIUM, NICKEL AND MOLUBDENUM). REF 01.06010.004 AVENIR STEM IS MANUFACTURED FROM PROTASUL-64 (MAINLY TITANIUM, ALUMNIUM, VANADIUM). REF 01.00013.408 DURASUL INLAY IS MANUFACTURED FROM POLYETHYLENE. AND REF 17.32.06 SULOX HEAD IS MANFACTURED FROM ALUMNIUM OXIDE. IT IS POSSIBLE THAT THE PATIENT HAS AN ALLERGY TOWARDS ONE OF THESE ELEMENTS INDICATED ABOVE. NICKEL ALLERGY IS COMMON AMONG SOME PEOPLE, THEREFORE THE PATIENT HAS TO UNDERGO AN ALLERGY TEST TO LEARN WHAT MIGHT CAUSE THE ALLERGIC REACTION. NEVERTHELES, RAW MATERIAL CERTIFICATE IS REVIEWED AND CONFIRMED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO THE MATERIAL SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PRODUCT DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. 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 - 2018 - 00560-1, 0009613350 - 2018 - 00561-1, 0009613350 - 2018 - 00562-1.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: DURASUL, ALPHA INSERT, HH/32, ITEM#: 01.00013.408, LOT#: 2858907. AVENIR MUELLER, STEM, STANDARD, UNCEMENTED, ITEM#: 01.06010.004, LOT#: 2854242. SULOX, HEAD, M, 32/0, TAPER 12/14, ITEM#: 17.32.06, LOT#: 2862438. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON MAY 17, 2018 TO THE APPROPRIATE REPRESENTATIVES. 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: 0009613350-2018-00560, 0009613350-2018-00561, 0009613350-2018-00562.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ALLOFIT ALLOCLASSIC SHL 50/HH ON AN UNKNOWN DATE AND IS BEING MONITORED DUE TO ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399674 ALLOFIT ALLOCLASSIC SHL 50/HH ALLOFIT ACETABULAR SYSTEM LZO ZIMMER GMBH N/A 2860270

    Patients

    Seq Age Sex Outcome Treatment
    1 Other