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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL KNEE II ULTRACONGRUENT ARTICULAR SURFACE SIZE 1, 2 RIGHT 9MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. NATURAL KNEE II ULTRACONGRUENT ARTICULAR SURFACE SIZE 1, 2 RIGHT 9MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Disassembly (1168); Unstable (1667); Noise, Audible (3273)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: unknown knee bearing cat#: unk, lot#: unk, unknown knee bearing cat#: unk, lot#: unk. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted. 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: 0001822565-2018-00440, 0001822565-2018-00441, 0001822565-2018-00439. Remains implanted.

 
Event Description

It was reported that the patient is experiencing instability, snapping noises, hardware backing out and pain following knee arthroplasty. Patient underwent a manipulation.

 
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Brand NameNATURAL KNEE II ULTRACONGRUENT ARTICULAR SURFACE SIZE 1, 2 RIGHT 9MM
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 Key7220927
MDR Text Key98276990
Report Number0001822565-2018-00439
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK070214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2018
Device MODEL NumberN/A
Device Catalogue Number00542802109
Device LOT Number62532045
OTHER Device ID NumberN/A
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 Received01/04/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/05/2013
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: 01/25/2018 Patient Sequence Number: 1
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