BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL, ALPHA INSERT, HOODED, II/32

    MDR report key: 7917512 · Received September 28, 2018

    Report

    Report Number
    0009613350-2018-01052
    Event Type
    Injury
    Date Received
    September 28, 2018
    Date of Event
    August 27, 2018
    Report Date
    February 26, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. DEVICE HISTORY RECORDS (DHR): 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: INFECTION. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP PROCEDURE ON (B)(6) 2018. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INFECTION ON (B)(6) 2018. PATIENT DEVELOPED A PUSS FILLED WOUND WHILE IN REHAB WARD. THE SURGEON BECAME AWARE OF THE WOUND. APPROXIMATELY 3 WEEKS POST OP. A WASH OUT AND DEBRIDEMENT WAS PERFORMED. APPROXIMATELY 3 WEEKS POST OP. THE INFECTION (INFECTION TYPE UNKNOWN) WAS NOT RESOLVED, WHICH RESULTED IN A REVISION SURGERY. THE SURGEON EXPLANTED ALL COMPONENTS AND CEMENT WITHOUT ANY COMPLICATIONS. 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. REVIEW OF PRODUCT DOCUMENTATION THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. INSTRUCTION FOR USE (IFU): GENERAL INFORMATION ON INDICATIONS, CONTRAINDICATIONS AND RISK FACTORS, PAGE 4/9: AN INFECTION IN THE REGION OF AN IMPLANT WILL HAVE NEGATIVE CONSEQUENCES FOR THE PATIENT IN MOST CASES, BECAUSE IT WILL USUALLY NECESSITATE REMOVAL OF THE IMPLANT. INDICATIONS AND CONTRAINDICATIONS FOR THE USE OF IMPLANTS MAY BE EITHER ABSOLUTE OR RELATIVE, AND MUST BE CAREFULLY WEIGHED, TAKING THE OVERALL CONDITION OF THE PATIENT INTO ACCOUNT INCLUDING OTHER ALTERNATIVE PROCEDURES, E.G., NON-SURGICAL TREATMENT, ARTHRODESIS. CONTRAINDICATIONS, PAGE 4/9: ACUTE, CHRONIC LOCAL OR SYSTEMIC INFECTIONS. RISK FACTORS, PAGE 5/9: PATIENT¿S RESISTANCE GENERALLY WEAKENED (HIV, TUMOR, INFECTION). ADVERSE EFFECTS, PAGE 7/9: THE GENERAL RISKS INVOLVED IN ENDOPROSTHETICS ARE ALLERGIC REACTIONS TO THE IMPLANT MATERIAL USED, LOOSENING, WEAR, CORROSION, INCORRECT POSITIONING, DISLOCATION, AGING, DETERIORATION AND FRACTURE OF THE IMPLANT OR IMPLANT PARTS. EARLY OR LATE INFECTIONS. CONCLUSION SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP PROCEDURE ON (B)(6) 2018. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INFECTION ON (B)(6) 2018. THE SURGEON EXPLANTED ALL COMPONENTS AND CEMENT WITHOUT ANY COMPLICATIONS. THE ALLOFIT ALLOCLASSIC SHELL WAS GAMMA STERILIZED. THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATE OF THE AFFECTED LOT: 2920056 (ALLOFIT ALLOCLASSIC SHELL) HAS BEEN REVIEWED AND WAS FOUND TO BE ACCORDING TO SPECIFICATION. THE DURASUL ALPHA INSERT WAS ETO (ETHYLENE OXIDE) STERILIZED. THE ETO STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE STERILIZATION CERTIFICATE OF THE AFFECTED LOT: 2920752 (DURASUL ALPHA INSERT) HAS BEEN REVIEWED AND WAS FOUND TO BE ACCORDING TO SPECIFICATION. THEREFORE, IT CAN BE EXCLUDED THAT AN UNSTERILE DEVICE WAS PRESENT AT THE TIME OF RELEASE. MOREOVER, NO TREND ON INFECTION HAS BEEN OBSERVED FOR THESE PRODUCT FAMILIES (ALLOFIT ALLOCALSSIC SHELL AND DURASUL ALPHA INSERT). THEREFORE, IT IS HIGHLY UNLIKELY THAT A DISADVANTAGEOUS PRODUCT DESIGN FAVORED OR CONTRIBUTED TO THE INFECTION. HOWEVER, THE IFU FOR ENDOPROSTHESIS STATES THAT EARLY OR LATE INFECTIONS ARE POSSIBLE CONSEQUENCES OF AN IMPLANT AND SHOULD BE CONSIDERED WHEN IMPLANTING ZIMMER BIOMET DEVICES. 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 EVENT UPDATE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM: ALLOFIT-S ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG , CATALOG #: 4265 , LOT #: 2920056. ITEM: CEMENT PRESSURIZER SMALL , CATALOG #: 00833408401 , LOT #: 63410268. ITEM: REVISION CENTRALIZER FOR USE W / CPT FEMORAL STEMS , CATALOG #: 32833305600 , LOT #: 62901597. ITEM: FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET , CATALOG #: 00811400100 , LOT #: 63895896. ITEM: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE , CATALOG #: 00801803202 , LOT #: 63775882. ITEM: 3 DOSE COMPACT VACUUM CEMENT MIXING SYSTEM , CATALOG #: 00504904501 , LOT #: 6381508. UDI # (B)(4). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K993259. 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. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON SEPTEMBER 21, 2018 TO THE APPROPRIATE REPRESENTATIVES. THE AVAILABILITY OF THE AFFECTED PRODUCT(S) (NON-AVAILABILITY WITH A RATIONALE) SURGICAL REPORT; ALL AVAILABLE X-RAYS DURING TIME IN- VIVO WITH PRINTED DATE; ALL AVAILABLE INTRAOPERATIVE PICTURES; WERE THERE ANY CONTRIBUTING CONDITIONS RELATED TO THE EVENT? (EX: TRAUMA, ILLNESS, PREVIOUS SURGERY, RELATED NON-COMPLIANCE, PATIENT ANATOMY). 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). NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4) REFERENCE NUMBER (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350 - 2018 - 01051.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH DURASUL, ALPHA INSERT, HOODED, II/32. SUBSEQUENTLY, APPROXIMATELY 5 MONTHS POST IMPLANTATION THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED A PUSS FILLED WOUND WHILE IN REHAB WARD. A WASH OUT AND DEBRIDEMENT WAS PERFORMED APPROXIMATELY 3 WEEKS POST OP. THE INFECTION WAS NOT RESOLVED, WHICH RESULTED IN THE REVISION SURGERY MENTIONED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761370 DURASUL, ALPHA INSERT, HOODED, II/32 N/A LPH ZIMMER GMBH N/A 2920752

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R