BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT

    MDR report key: 6875817 · Received September 19, 2017

    Report

    Report Number
    3005751028-2017-02706
    Event Type
    Injury
    Date Received
    September 19, 2017
    Date of Event
    October 25, 2017
    Report Date
    April 22, 2020
    Manufacturer
    ZIMMER TMT
    Product Code
    JDI
    PMA / PMN Number
    PK050937
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: A2; B2; B3; B4; B5; D7; D11; G4; G7; H1; H2; H6 D11: PART# 110024465 LOT# 146430 PART# EP-200152 LOT# 051140 PART# 110010267 LOT# 3891352 PART# 0100561317 LOT# 2860089 PART# 00877702802 LOT# 2891878 PART# 00662406525 LOT# 63596947 PART# 00662406530 LOT# 63401095 PART# 00662406540 LOT# 63615169 PART# 00662406535 LOT# 62766982 PART# 010000999 LOT# 3954497 PART# 010000999 LOT# 3970980 PART# 010000998 LOT# 3784469 PART# 010000997 LOT# 3593724 NO CHANGE IN THE ROOT CAUSE OF THE INVESTIGATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    UPON FURTHER EXAMINATION, IT WAS FOUND THAT THE PATIENT HAD UNDERWENT A SECOND REVISION APPROXIMATELY 4 MONTHS AFTER THE FIRST REVISION DUE TO INFECTION. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED FOR EVALUATION, THEREFORE ONLY A DEVICE HISTORY REVIEW WAS PERFORMED. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE COMPONENT AND NO DEVIATIONS OR ANOMALIES WERE FOUND. NO X-RAYS OR SURGICAL NOTES WERE PROVIDED. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REVIEW OF THE STERILIZATION CERTIFICATE FOR THE DEVICE IDENTIFIED NO ANOMALIES. ALL THE REPORTED DEVICES LEFT ZIMMER BIOMET STERILE. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. SHOULD ADDITIONAL INFORMATION BE OBTAINED TO FURTHER THIS INVESTIGATION, THIS REPORT SHALL BE UPDATED. DEVICE LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN ANTICIPATED REVISION SURGERY DUE TO INFECTION. IF ADDITIONAL INFORMATION IS MADE AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT HIP ARTHROPLASTY ON (B)(6) 2017 DUE TO UNKNOWN REASONS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS ON (B)(6) 2017. NO FURTHER INFORMATION HAS BEEN PROVIDED. THERE IS NO EVEIDENCE THAT THE TM COLUMN BUTTRESS AUGMENT (TMT DESIGNED CONTROLLED DEIVCE) WAS REVISED. TM ACETABULAR AUGMENT (TMT DESIGNED CONTROLLED DEIVCE) WAS IMPLANTED DURING THIS SURGERY. ON (B)(6) THE PMI GROUP IS REQUESTING ACETABULAR COMPONENT FLANGE CONSISTENT WITH SURGEON PREVIOUS DESIGNS FOR A REVISION ON (B)(6) 2017. ON (B)(6) THE GROUP NOTED THAT THE PATIENT IS BEING REVISED FOR INFECTION. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT HIP ARTHROPLASTY ON (B)(6) 2017 DUE TO UNKNOWN REASONS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS ON (B)(6) 2017. NO FURTHER INFORMATION HAS BEEN PROVIDED. THERE IS NO EVIDENCE THAT THE TM COLUMN BUTTRESS AUGMENT (TMT DESIGNED CONTROLLED DEIVCE) WAS REVISED. TM ACETABULAR AUGMENT (TMT DESIGNED CONTROLLED DEIVCE) WAS IMPLANTED DURING THIS SURGERY. ON (B)(6) 2017, IT WAS NOTED THAT THE PATIENT IS BEING REVISED FOR INFECTION. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657194 TM ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT TM ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT JDI ZIMMER TMT UNK 63271869

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R SEE NARRATIVE IN H10