BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL 6.0X132

    MDR report key: 10257376 · Received July 10, 2020

    Report

    Report Number
    0001825034-2020-02697
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    June 22, 2020
    Report Date
    November 9, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D7: NOT EXPLANTED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11: M2A MODULAR HEAD 38MM 11-173660 LOT 521480. M2A 38MM X48 RD118848 LOT#982610. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G4, H2, H3, H6. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS INDICATE THAT THE PATIENT UNDERWENT AN INITIAL LEFT THA DUE TO OSTEOARTHRITIS; NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. PATIENT WAS REVISED DUE TO AN IDENTIFIED MASS. PATIENT DEVELOPED SWELLING AND LARGE SOFT TISSUE TUMOR CREATING VASCULAR COMPROMISE AND VENOUS THROMBOSIS REMOVED 3 MONTHS PRIOR BY VASCULAR SURGERY TEAM. STEM AND CUP WERE WELL FIXED; ELECTED NOT TO REVISE HOWEVER OSTEOLYTIC REGRESSION OF SUPPORTIVE BONE OF BOTH IMPLANTS. NO ABNORMAL FINDINGS OF TRUNNION AND ARTICULAR SURFACE. PSEUDOCAPSULE NOTED POSTERIORLY, DENSE FIBROUS TISSUE EXCISED AND SENT TO PATHOLOGY. HEAD WAS EXPLANTED AND REPLACED WITH DUAL ARTICULATION. NO INTRAOPERATIVE COMPLICATIONS NOTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY SEVENTEEN YEARS POST IMPLANTATION DUE TO A PSUEDOTUMOR, SWELLING, ALTR, DVT, AND OSTEOLYSIS. DURING THE PROCEDURE HEAD, CUP AND STEM COMPONENTS WERE REMOVED AND REPLACED WITH A DUAL MOBILITY SYSTEM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE: (B)(6) 2003. CONCOMITANT MEDICAL DEVICES: ITEM #: UNKNOWN, UNKNOWN HEAD, LOT #: UNKNOWN; ITEM #: UNKNOWN, UNKNOWN CUP, LOT #: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT WAS RETURNED TO THE CUSTOMER AND THE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 02695 HEAD, 0001825034 - 2020 - 02696 CUP.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY SEVENTEEN YEARS POST IMPLANTATION DUE TO A MASS. DURING THE PROCEDURE HEAD, CUP AND STEM COMPONENTS WERE REMOVED AND REPLACED WITH A DUAL MOBILITY SYSTEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723871 TAPERLOC POR FMRL 6.0X132 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 931140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R