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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD XP TIBIAL TRAY PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. VANGUARD XP TIBIAL TRAY PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Nerve Damage (1979)
Event Date 04/21/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Date of birth patient was born in 1940. Concomitant medical products: vanguard xp femoral, cat#: 195214 lot#: 277150, vanguard xp lateral tibial bearing, cat#: 195814 lot#: 519100, vanguard xp medial tibial bearing, cat#: 195884 lot#: 433390. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-07884, 0001825034-2017-07885, 0001825034-2017-07886, 0001825034-2017-07887.

 
Event Description

It was reported that the patient was revised to address nerve injury. Attempts have been made and no further information has been provided.

 
Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. No revision occurred.

 
Event Description

It was reported that patient experienced a nerve injury approximately 2. 5 years post implantation.

 
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Brand NameVANGUARD XP TIBIAL TRAY
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 Key6927784
MDR Text Key88928138
Report Number0001825034-2017-07884
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK132873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,STUDY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/02/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/07/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date01/31/2019
Device MODEL NumberN/A
Device Catalogue Number195755
Device LOT Number677650
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 Received10/31/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/16/2014
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: 10/07/2017 Patient Sequence Number: 1
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