BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX OPTION, HEAD, S, 36/-3.0, TAPER 12/14

    MDR report key: 8900444 · Received August 16, 2019

    Report

    Report Number
    0009613350-2019-00497
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    December 24, 2015
    Report Date
    March 17, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    K073567
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: CORRECTION: B4 - G4 - G7 - H10. D11 - MEDICAL PRODUCTS AND THERAPY DATE: DETAIL OF PRODUCT: ITEM NUMBER: 00630505636. ITEM NAME: LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL. LOT # 62916914. ITEM NUMBER: AR-182SSF. ITEM NAME: SUTURE ANCHO. LOT # 1240438. ITEM NUMBER: 00625006525. ITEM NAME BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH. LOT # 61999335. TREND ANALYSIS: NO TREND HAS BEEN IDENTIFIED. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH PRODUCT ON (B)(6) 2015 AND UNDERWENT REVISION SURGERY ON (B)(6) 2015 DUE TO INFECTION. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICE ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THIS DEVICE IS INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED FROM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. RAW MATERIAL CERTIFICATE REVIEWED ON: 06-MAR-2020. THE REVIEW SHOWED THAT THE MATERIALS WERE MANUFACTURED ACCORDING TO SPECIFICATION. STERILIZATION CERTIFICATE REVIEWED ON: 06-MAR-2020. THE REVIEW SHOWED THAT THE DEVICES WERE STERILIZED ACCORDING TO SPECIFICATION. CONCLUSION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH PRODUCT ON (B)(6) 2015 AND UNDERWENT REVISION SURGERY ON (B)(6) 2015 DUE TO INFECTION. IN VIVO TIME OF THE DEVICE IS 1 MONTH. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE AVAILABLE INFORMATION, WE WERE NOT ABLE TO IDENTIFY AN EXACT ROOT CAUSE FOR THIS ISSUE. 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

    PLEASE REFER TO REPORT 0009613350-2019-00497.

    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. WHERE LOT NUMBERS WERE RECEIVED FOR THE 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¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON RIGHT SIDE AND UNDERWENT REVISION DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694154 BIOLOX OPTION, HEAD, S, 36/-3.0, TAPER 12/14 BIOLOX OPTION, HEAD LZO ZIMMER GMBH N/A 2767376

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R