BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 HI-WALL E1 LINER 36MM H

    MDR report key: 6411480 · Received March 16, 2017

    Report

    Report Number
    0001825034-2017-01695
    Event Type
    Injury
    Date Received
    March 16, 2017
    Date of Event
    January 31, 2016
    Report Date
    April 11, 2022
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PBI
    UDI-DI
    00880304527133
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. THIS DEVICE WAS USED FOR TREATMENT. DEVICE HISTORY REPORT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. THIRD REVISION REPORTED PRE AND POST DIAGNOSIS AS FAILED RIGHT TOTAL HIP ARTHROPLASTY. THERE WAS NO FAILURE OF THE POLYETHYLENE AND EXCELLENT CIRCUMFERENTIAL INGROWTH ON THE ACETABULAR COMPONENT. THE SCIATIC NERVE THAT WAS FOUND TO BE INTACT, ATRAUMATIC AND CONTINUOUS, THE THA HAD FULL RANGE OF MOTION AND THERE WERE NO TRANSFUSIONS OR COMPLICATIONS. THERE WERE THREE EVENT OF DISLOCATION; THERE WERE NO SURGERIES BUT RECOMMENDED THERAPEUTIC EXERCISE, GAIT TRAINING, HOME PROGRAM INSTRUCTION. PHYSICAL THERAPY TREATMENT CONSISTED OF PROGRESSIVE THERAPEUTIC EXERCISES AND MANUAL THERAPY AND SOFT TISSUE MOBILIZATION TECHNIQUES. ROOT CAUSE WAS UNABLE TO 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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOLOX DELTA FEMORAL HEAD, CATALOG#: 650-1057, LOT#: 592710; G7 ACETABULAR CUP, CATALOG#: 010000669, LOT#: 3350575; TAPER ADAPTER, CATALOG#: 650-1068, LOT#: 130540; TAPERLOC FEMORAL STEM, CATALOG#: 103207, LOT#: 220990; G7 SCREW, CATALOG#: 010000999, LOT#: 3365486 & 3369626. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 1825034-2017-01693, 1825034-2017-01695.

    Description of Event or Problem · 1

    IT WAS REPORTED IN MEDICAL NOTES RECEIVED THAT PATIENT UNDERWENT A CLOSED REDUCTION PROCEDURE APPROXIMATELY 7 MONTHS POST-IMPLANTATION DUE TO DISLOCATION. SUBSEQUENTLY, PATIENT UNDERWENT A SECOND CLOSED REDUCTION PROCEDURE APPROXIMATELY 12 MONTHS POST-IMPLANTATION. PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY 14 MONTHS POST-IMPLANTATION DUE TO THE REOCCURRING DISLOCATION. DURING THE PROCEDURE, THE FEMORAL HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192743 G7 HI-WALL E1 LINER 36MM H PROSTHESIS, HIP PBI BIOMET ORTHOPEDICS N/A 3123575 00880304527133
    192753 G7 HI-WALL E1 LINER 36MM H PROSTHESIS, HIP PBI BIOMET ORTHOPEDICS N/A 3123575 00880304527133

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization| R