BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BI-METRIC HIP

    MDR report key: 4603510 · Received March 16, 2015

    Report

    Report Number
    0001825034-2015-00993
    Event Type
    Injury
    Date Received
    March 16, 2015
    Report Date
    October 26, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK143009
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE MANUSCRIPT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN; CATALOG NUMBER, LOT NUMBER AND EXPIRATION DATE - UNKNOWN; DATE IMPLANTED - UNKNOWN; DATES EXPLANTED - UNKNOWN ; INITIAL REPORTER -THE ARTICLE WAS WRITTEN BY SUEYOSHI, T., ET AL; MANUSCRIPT: JOINT REPLACEMENT SURGEONS OF INDIANA RESEARCH FOUNDATION. MANUFACTURE DATE ¿ UNKNOWN. IT IS LIKELY THAT THESE COMPLICATIONS HAVE ALREADY BEEN REPORTED; HOWEVER, IT CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION MADE AVAILABLE IN THE ARTICLE. SHOULD ADDITIONAL INFORMATION RELATING TO THE EVENTS BE RECEIVED, THE UPDATED INFORMATION WILL BE FORWARDED TO THE FDA.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) AND COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 · 1

    INFORMATION WAS RECEIVED BASED ON A REVIEW OF A MANUSCRIPT TITLED, "SHORT-TERM OUTCOMES OF THE SECOND GENERATION UNCEMENTED STEM IN TOTAL HIP ARTHROPLASTY¿ WHICH REVIEWED THE SHORT-TERM OUTCOMES OF ECHO BI-METRIC COMPARING IT TO ITS BI-METRIC PREDECESSOR. THIS MANUSCRIPT REPORTS THE SHORT-TERM OUTCOMES OF ECHO BI-METRIC STEM AND HOW RENEWED FEATURES AFFECT THE OUTCOMES INCLUDING HARRIS HIP SCORES AND RADIOGRAPHIC ANALYSIS. FROM 1986 TO 2005, SIXTEEN HUNDRED AND SIX (1606) TOTAL HIP ARTHROPLASTIES WERE PERFORMED USING AN UNCEMENTED BI-METRIC FEMORAL STEM. FROM 2005 TO 2014, THIRTEEN HUNDRED AND SEVENTY-FOUR (1374) TOTAL HIP ARTHROPLASTIES WERE PERFORMED USING THE ECHO BI-METRIC FPP STEM AND THREE HUNDRED AND SIXTY-SIX (366) TOTAL HIP ARTHROPLASTIES WERE PERFORMED WITH THE ECHO BI-METRIC RPP STEM. OF THESE, FOURTEEN HUNDRED AND NINETY-SEVEN (1497) BI-METRIC STEMS IN 1280 PATIENTS, 1277 ECHO FPP IN 1104 PATIENTS AND 366 ECHO RPP IN 317 PATIENTS WERE INCLUDED IN THIS MANUSCRIPT. POSTOPERATIVELY, THERE WERE THREE (3) DISLOCATIONS, THREE (3) INFECTIONS, FOUR (4) IRRITATION AND DRAINAGES AND ONE (1) DVT (DEEP VEIN THROMBOSIS) FOR ECHO FPP. THERE WAS ONE (1) IRRIGATION AND DRAINAGE FOR ECHO RPP. THERE WERE THIRTY-NINE (39) DISLOCATIONS, THREE (3) INFECTIONS, ONE (1) IRRIGATION AND DRAINAGE AND TWO (2) DVTS FOR BI-METRIC. REGRESSION ANALYSIS REVEALED THAT POSTERIOR APPROACH HAD 2.2 TIMES ODDS OF DISLOCATION COMPARED TO ANTERIOR APPROACH IN THE STUDY. IT ALSO REVEALED THAT THE FEMORAL HEAD OF SIZE 28MM AND UNDER HAD 9.09 TIMES ODDS OF DISLOCATION COMPARED TO THAT OF SIZE 32 MM, AND 22.73 TIMES ODDS OF DISLOCATION COMPARED TO THAT OF SIZE 36 AND OVER. IN CONCLUSION, THE SECOND GENERATION UNCEMENTED STEM; ECHO FPP AND ECHO RPP DEMONSTRATED EXCELLENT OUTCOMES WITH 100% SURVIVORSHIP AND LESS DISLOCATION. THERE WAS NO STATISTICAL DIFFERENCE IN SURVIVORSHIP OR HARRIS HIP SCORES BETWEEN THEM. THE ECHO FPP AND ECHO RPP HAVE A GOOD START AND IT IS EXPECTED TO HAVE EXCELLENT OUTCOMES IN THE FUTURE RESEARCH AND ANALYSIS.

    Description of Event or Problem · 1

    THIS REPORT ADDRESSES: THIRTY-NINE (39) HIP DISLOCATIONS POST-OP PRIMARY THA WITH BI-METRIC DEVICE. ADDITIONAL INFORMATION REVEALED THAT THE BI-METRIC GROUP WERE MOSTLY PERFORMED THROUGH A POSTERIOR APPROACH AND USED SMALLER HEAD SIZE (28 CM OR BELOW). THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177254 UNKNOWN BI-METRIC HIP PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention