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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING (CPS) LEFT 16 MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING (CPS) LEFT 16 MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Damage to Ligament(s) (1952)
Event Date 02/04/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it's been discarded by the hospital. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It has been reported that a patient underwent a revision knee procedure after developing medial collateral ligament and lateral collateral ligament laxity. There is no additional information.

 
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Brand NameARTICULAR SURFACE FIXED BEARING (CPS) LEFT 16 MM
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 Key9777223
MDR Text Key189466045
Report Number0001822565-2020-00764
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2019
Device MODEL NumberN/A
Device Catalogue Number42512600716
Device LOT Number62842868
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 Received05/18/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/31/2014
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: 03/02/2020 Patient Sequence Number: 1
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