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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 40MM G; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 40MM G; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Positioning Problem (3009)
Patient Problem No Code Available (3191)
Event Date 08/07/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item number 010000666, item name g7 acetabular shell, lot number 6511886, item number 010000748, item name g7 neutral arcomxl lnr 40mm g, lot number 6448445, item number: unknown, item name: unknown head, lot number: unknown, item number: unknown, item name: unknown stem, lot number: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03872, 0001825034 - 2019 - 03874.
 
Event Description
It was reported that during an initial hip arthroplasty multiple liners would not seat into the shell.The shell was removed and replaced.A different shell and liner were used to complete the case.A surgical delay of one hour occurred.No additional information is available.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Upon visual inspection the shell shows scuffing around the outside lip with no further visible damage.The returned neutral liner shows damage to the scallops in the form of impaction below the scallop chamfer with no further visible damage to the liner.The hi-wall liner that was returned showed scuffing around the scallops with no visible damage to the outside radius.Root cause of the 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.
 
Event Description
No additional information at this time.
 
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Brand Name
G7 HI-WALL ARCOMXL LNR 40MM G
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8949287
MDR Text Key156094151
Report Number0001825034-2019-03873
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,health profession
Type of Report Initial,Followup
Report Date 12/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number010000826
Device Lot Number6544576
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2019
Was the Report Sent to FDA? No
Date Manufacturer Received11/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight99
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