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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 32MM F; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 32MM F; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Foreign: (b)(6).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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: 0001825034-2020-02899, 0001825034-2020-02911.
 
Event Description
It was reported that during implantation of the g7 system, the surgeon could not lock the liner into place.A smaller size was used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
Upon reassessment of the reported event, the event was determined to be not reportable as there was no device problem found but rather off-label use of the device.The surgeon used ti screws that are not compatible with g7 cups, the ti screws would not sit flush in the cup leading to the liner not seating as well.The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
Upon reassessment of the reported event, the event was determined to be not reportable as there was no device problem found but rather off-label use of the device.The surgeon used ti screws that are not compatible with g7 cups, the ti screws would not sit flush in the cup leading to the liner not seating as well.The initial report was forwarded in error and should be voided.
 
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Brand Name
G7 HI-WALL ARCOMXL LNR 32MM F
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10311003
MDR Text Key200319229
Report Number0001825034-2020-02894
Device Sequence Number1
Product Code PBI
Combination Product (y/n)N
PMA/PMN Number
K121874
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number010000811
Device Lot Number6738419
Was the Report Sent to FDA? No
Date Manufacturer Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
CAT#: 010000665 G7 SHELL LOT#: 6691969.; UNKNOWN SCREW.
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