BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR MULLER, STEM, LATERAL, UNCEMENTED, HA, 7, TAPER 12/14

    MDR report key: 8150613 · Received December 11, 2018

    Report

    Report Number
    0009613350-2018-01213
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 18, 2018
    Report Date
    June 26, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024479548
    PMA / PMN Number
    K123392
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED. CONCOMITANT MEDICAL PRODUCTS: ASSOCIATED ITEM NUMBER: 00877503602. ITEM NAME: BIOLOX DELTA, CERAMICFEMORAL HEAD, M, 36/0, TAPER 12/14. LOT #2946139. ASSOCIATED ITEM NUMBER: 12-115121. ITEM NAME: CER BIOLOXD MOD HD 36MM STD NK. LOT # 2943888. ASSOCIATED ITEM NUMBER: 010000668. ITEM NAME. G7 PPS LTD ACET SHELL 62H. LOT # 3881609. ASSOCIATED ITEM NUMBER: 010000860. ITEM NAME: G7 NEUTRAL E1 LINER 36MM H. LOT # 3873835. ASSOCIATED ITEM NUMBER: 11-300818. ITEM NAME: ARCOS 18X150MM SPL TPR DIST M. LOT # 842240. ASSOCIATED ITEM NUMBER: 11-301353. ITEM NAME: ARCOS CON SZ C HI 80MM M SZ C. LOT # 729060. ASSOCIATED ITEM NUMBER: 00223200418. ITEM NAME: CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH. LOT # 64123314. ASSOCIATED ITEM NUMBER: 00223200418. ITEM NAME: CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MMLENGTH. LOT # 6412331. X-RAYS WERE RECEIVED AND WILL BE REVIEWED WITHIN INVESTIGATION PROCESS. 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).

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. DHR-REVIEW: REF:01.06010.107 ; LOT:2924249 - YIELD:40 - DELIVERED:39 - SCRAPPED:01 - REASON FOR SCRAPPING:SURFACE DAMAGES 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: BONE FRACTURE EVENT DESCRIPTION: IT WAS REPORTED THAT THE AVENIR MÜLLER STEM WAS REVISED 6 DAYS AFTER IMPLANTATION DUE TO PERIPROSTHETIC FRACTURE WHICH MAY HAVE OCCURRED INTRAOPERATIVELY. REVIEW OF RECEIVED DATA: - 1 X-RAY DATED (B)(6) 2018 IS RECEIVED FOR THE INVESTIGATION. IT CAN NOT BE SAID WITH CERTAINTY WHETHER A FRACTURE OR FISSURE CAN BE DETECTED IN THE AREA OF THE STEM. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THIS DEVICE IS INTENDED FOR TREATMENT. / ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. - SURGICAL TECHNIQUE WAS NOT REVIEWED AS NO SURGICAL REPORT WAS RECEIVED TO COMPARE WHETHER THE SURGICAL TECHNIQUE WAS FOLLOWED OR NOT. CONCLUSION SUMMARY: THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). IN THE CASE OF A MISMATCH BETWEEN THE STEM AND THE FEMUR, IT IS POSSIBLE IN PRINCIPLE FOR A FISSURE OR FRACTURE TO OCCUR DURING CEMENTLESS STEM IMPLANTATION. HOWEVER, IT IS UNKNOWN WHETHER THE BONE FRACTURE OCCURRED DURING OPERATION OR AFTER THE OPERATION. THE RECEIVED X-RAY DID NOT CONFIRM ANY EXISTENCE OF A BONE FRACTURE. BASED ON THE GIVEN INFORMATION THE COMPLAINT COULD NOT BE CONFIRMED. 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.

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14, CATALOG NO#: 00-8775-036-02, LOT#: 2946139. THERAPY DATE: (B)(6) 2018. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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

    PATIENT HAS BEEN IMPLANTED ON RIGHT SIDE AND UNDERWENT REVISION DUE TO PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992192 AVENIR MULLER, STEM, LATERAL, UNCEMENTED, HA, 7, TAPER 12/14 AVENIR MULLER, STEM LZO ZIMMER GMBH N/A 2924249 00889024479548

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE| SEE H10 NARRATIVE