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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD PS TIB BRG 71/75X10 PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. E1 VNGD PS TIB BRG 71/75X10 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Unstable (1667)
Patient Problems Fall (1848); Hematoma (1884); Loss of Range of Motion (2032); Synovitis (2094); Reaction (2414)
Event Date 04/09/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: bone cement pn 545035500 lot unknown , stem 40mm pn 141314 lot 255700, vanguard femur 70mm pn 184512 lot unknown, tibia 79mm pn 141275 lot unknown, regenerex patella 34mm pn 141357 lot unknown. Customer has not indicated that the product will be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04457, 0001825034-2019-04466.

 
Event Description

It was reported the patient underwent a right knee revision of the right knee patella and tibial bearing approximately five years post implantation due complications from a fall. Revision operative report notes the patella pegs were fractured and blackened synovium. Legal counsel reports that the patient continues to have pain and mobility dysfunction interfering with daily life. No additional information is available at this time.

 
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Brand NameE1 VNGD PS TIB BRG 71/75X10
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 Key9184913
MDR Text Key162435977
Report Number0001825034-2019-04457
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK080528
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2019
Device MODEL NumberN/A
Device Catalogue NumberEP-183640
Device LOT Number309810
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/15/2014
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: 10/14/2019 Patient Sequence Number: 1
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