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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscular Rigidity (1968); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Date of birth: (b)(6). Implant date - unknown month and day in 2014. Event date and explant date - unknown month and day in 2017. Medical products: series a pat thn 34 3 peg, catalog # 184786, lot # unknown; tinbn vg int ps anat fm l 65mm ,catalog # 183128tnbn, lot # unknown; tnbn pol cocr fin tib tray 71, catalog # 141253tnbn, lot # unknown. Customer has indicated that the product will not be returned because product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filled for this event: 0001825034-2021-02130. Product location is unknown.
 
Event Description
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient was revised due to pain. It is unknown what products were revised. Attempt for further information has been made, but no further information has been provided.
 
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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 Key12216713
MDR Text Key263096732
Report Number0001825034-2021-02131
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K113550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberEP-183640
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/23/2021 Patient Sequence Number: 1
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