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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 28MM D; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 28MM D; PROSTHESIS, HIP Back to Search Results
Catalog Number 010000799
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified.No patient or surgical involvement.No further information available at this time.
 
Manufacturer Narrative
It was determined this device did not cause or contribute to a serious injury and has not been identified as a reportable malfunction.Please void this submission.
 
Event Description
It was determined this device did not cause or contribute to a serious injury and has not been identified as a reportable malfunction.Please void this submission.
 
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Brand Name
G7 HI-WALL ARCOMXL LNR 28MM D
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8773078
MDR Text Key150975347
Report Number0001825034-2019-02901
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
Type of Report Initial,Followup
Report Date 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/24/2022
Device Catalogue Number010000799
Device Lot Number6033027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2019
Was the Report Sent to FDA? No
Date Manufacturer Received12/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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