BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14

    MDR report key: 21114644 · Received January 9, 2025

    Report

    Report Number
    0009613350-2025-00011
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    February 21, 2023
    Report Date
    August 29, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024590977
    PMA / PMN Number
    K193030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE NOT PROVIDED. HOWEVER, THE IMPLANT STICKERS FOR THE IMPLANTATION AND REVISION SURGERY WERE PROVIDED. BASED ON THESE STICKERS, THE REPORTED EVENT CAN BE CONFIRMED. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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). D10. BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14 ITEM# 00877503201 LOT# 3133012. 48MM O.D. SIZE GG POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH GG LINERS ITEM# 00875304801 LOT# 65433673. 32MM I.D. SIZE GG ELEVATED RIM LINER USE WITH 48MM O.D. SIZE GG SHELL ITEM# 00875200832 LOT# 65310435. UNCEMENTED SINGLE PACK DOME HOLE PLUG ITEM# 00875300001 LOT# 65377200. G2. REPORT SOURCE: SPAIN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS FOR THE IMPLANTATION SURGERY WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL WITH THE FOLLOWING FINDINGS: THE PROCEDURE WAS PERFORMED VIA A LATERAL APPROACH. THE PATIENT DEMONSTRATED GOOD RANGE OF MOTION (ROM) INTRAOPERATIVELY. NO COMPLICATIONS WERE OBSERVED. POSTOPERATIVE X-RAY CONFIRMED CORRECT IMPLANT PLACEMENT AND SATISFACTORY ALIGNMENT OF THE FEMUR. MEDICAL RECORDS LEADING UP TO AS WELL AS FOR THE REVISION SURGERY WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL WITH THE FOLLOWING FINDINGS: THE PATIENT REPORTED PAIN WHILE WALKING WITH PARTIAL WEIGHT-BEARING USING A WALKER. AN X-RAY SHOWED A SPIRAL BURST FRACTURE DUE TO OSTEOPOROSIS WITH FEMORAL IMPLANT IMPACTION, AND REVISION SURGERY WITH A HOOK PLATE WAS PLANNED. AFTER THIS, REVISION SURGERY WAS PERFORMED USING THE PREVIOUS INCISION. THE UNCEMENTED STEM WAS REMOVED, THE VANCOUVER TYPE B2 PERIPROSTHETIC FRACTURE WAS REDUCED WITH A GTR PLATE, SCREWS, AND BONE MATRIX, AND A NEW CEMENTED FEMORAL STEM WITH A CERAMIC HEAD WAS IMPLANTED. A DRAIN WAS PLACED, AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. HOWEVER, THE OUTCOME OF THE INVESTIGATION REMAINS UNCHANGED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. 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

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL HIP REPLACEMENT. SUBSEQUENTLY, TWO WEEKS POST IMPLANTATION, EXPERIENCED A PERIPROSTHETIC FRACTURE AND REVISION SURGERY WAS PERFORMED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AND INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, TWO WEEKS POST IMPLANTATION, EXPERIENCED A PERIPROSTHETIC FRACTURE TO THE GRATER TROCHANTER AND REVISION SURGERY WAS PERFORMED. THE HEAD AND STEM WERE EXCHANGED FOR A CEMENTED ONE, A HOOK PLATE AND SCREWS, BONE MATRIX AND DISTAL CENTRALIZER. THE SHELL AND LINER REMAINED IMPLANTED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377073 AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH N/A 3111300 00889024590977

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Hospitalization| R SEE H11 NARRATIVE.