BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 54F

    MDR report key: 11783966 · Received May 6, 2021

    Report

    Report Number
    0001825034-2021-01333
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    January 14, 2021
    Report Date
    May 21, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D10: ITEM# 20124006 / ITEM NAME G7 LONGEVITY HIGH WALL40MM F / LOT# 64577165 ITEM# 00625006530 / ITEM NAME BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH / LOT# J6813932 ITEM# 00625006525 / ITEM NAME BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH / LOT# J6817641 ITEM# 00625006520 / ITEM NAME BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH / LOT# 64558809 ITEM# 650-1058 / ITEM NAME CER BIOLOXD OPTION HD 40MM 0 / LOT# 3032856 ITEM# 650-1064 / ITEM NAME CER OPTION TYPE 1 TPR SLEVE -6 PE 1 / LOT# 3031442 ITEM# 51-108080 / ITEM NAME TPRLC 133 MP T1 PPS SO 8X101MM / LOT# 6685818  NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A DEFINITIVE ROOT CAUSE CANNOT 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

    IT WAS REPORTED THE PATIENT STATED SHE UNDERWENT A THA. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION 3 MONTHS LATER. SURGEON REPORTED THAT LINER HAD DISSOCIATED AND THERE WAS DIRECT CERAMIC HEAD CONTACT WITH SHELL, LEADING TO METALLOSIS, METALLIC DEBRIS, IMPLANT WEAR TO SHELL, AND PSEUDOTUMOR. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: ITEM# 20124006 / ITEM NAME G7 LONGEVITY HIGH WALL40MM F / LOT# UNKNOWN; ITEM# 00625006530 / ITEM NAME BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH / LOT# UNKNOWN; ITEM# 00625006525 / ITEM NAME BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH / LOT# UNKNOWN; ITEM# 00625006520 / ITEM NAME BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH / LOT# UNKNOWN; ITEM# 650-1058 / ITEM NAME CER BIOLOXD OPTION HD 40MM 0 / LOT# UNKNOWN; ITEM# 650-1064 / ITEM NAME CER OPTION TYPE 1 TPR SLEVE -6 PE 1 / LOT# UNKNOWN; ITEM# 51-108080 / ITEM NAME TPRLC 133 MP T1 PPS SO 8X101MM / LOT# UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS SINCE LOCATION UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT STATED SHE UNDERWENT A THA SIX(6) MONTHS AGO, THE PATIENT UNDERWENT A REVISION ON A UNKNOWN DATE DUE TO THE HI-WALL LINER DISENGAGING AND A MAL-POSITIONED CUP. PATIENT STATED SHE HAS EXPERIENCED SQUEAKING, POPPING AND SLIPPING OF THE HIP AND XRAYS HAVE SHOWN THE LINER APPEARS LOOSE. PATIENT STATED HER HIP ALMOST POPS OUT BUT THEN POPS BACK IN TO PLACE, PUSHING ON THE PELVIS AND JOINT AREA CAUSING PAIN, MISALIGNMENT AND HINDERS THE ABILITY TO WALK. 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
    682745 G7 PPS LTD ACET SHELL 54F PROSTHETIC, HIP PBI ZIMMER BIOMET, INC. N/A 6803742

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R