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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGXP XP E1 TIB BRG RM 9X79 PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. VGXP XP E1 TIB BRG RM 9X79 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 04/08/2014
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint- (b)(4). Concomitant products: part 195204, lot 999140- vgxp intlk fmrl rt 62. 5; part 195252, lot 928810- vngd xp inlk pri tib tray 79mm; part 195339, lot 868070- vgxp xp e1 tib brg rl 9x79. Customer has indicated that the product will not be returned to zimmer biomet for investigation. Multiple mdr reports were filed for this event, please see associated reports: mfr 0001825034-2018-01193, mfr 0001825034-2018-01194, mfr 0001825034-2018-01195. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies related to the complaint were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. 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. This report is being submitted late as it has been identified in remediation.
 
Event Description
Clinical study 504 - extreme pain post-surgery.
 
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Brand NameVGXP XP E1 TIB BRG RM 9X79
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7288095
MDR Text Key100645111
Report Number0001825034-2018-01196
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK122160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Type of Report Initial
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2018
Device Model NumberN/A
Device Catalogue Number195409
Device Lot Number868650
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/21/2018 Patient Sequence Number: 1
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