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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD XP TIBIAL BEARING-LEFT MEDIAL PROSTHESIS,KNEE

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ZIMMER BIOMET, INC. VANGUARD XP TIBIAL BEARING-LEFT MEDIAL PROSTHESIS,KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Claudication (2550)
Event Date 06/26/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: vanguard xp femoral interlok with pegs, catalog#: 195214, lot#: 990240. Vanguard xp tibial tray-interlok, catalog#: 195248, lot#: 752560. Vanguard xp tibial bearing-left lateral, catalog#: 195367, lot#: 677800. The device was not returned for evaluation due to unknown location. Review of the device history record (dhr) found no deviations or anomalies. Review of complaint history for same or similar issue identified five additional complaints for part (item) number and two additional complaints were identified for part/lot combination. Without the opportunity to evaluate the device, the complaint was not confirmed and root cause could not be determined. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. Associated risk table lists "miscellaneous user needs (general post-operative pain )¿. Following review, no new risks were identified. 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: 0001825034-2018-01255/01256/01258. This report is being submitted late as it has been identified in remediation.
 
Event Description
It was reported as part of a clinical study that a patient underwent a left knee procedure on (b)(6) 2014. Subsequently, the patient reported moderate pain, problems with walking and performing daily activities, often limping, and difficulty using stairs during the six (6) month, one (1) and two (2) year follow up visits. It was also reported that the patient was still using a cane 2 years post implant. Attempts have been made and no further information has been provided.
 
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Brand NameVANGUARD XP TIBIAL BEARING-LEFT MEDIAL
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 Key7288835
MDR Text Key100699118
Report Number0001825034-2018-01259
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 Received02/22/2018
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 Number195437
Device Lot Number825590
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 Manufactured10/19/2013
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: 02/22/2018 Patient Sequence Number: 1
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