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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK RADIAL HEAD ELBOW PROSTHESIS

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ZIMMER BIOMET, INC. UNK RADIAL HEAD ELBOW PROSTHESIS Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscular Rigidity (1968); Loss of Range of Motion (2032); Scar Tissue (2060); Limited Mobility Of The Implanted Joint (2671)
Event Date 04/07/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent an initial left orif, lateral ligament repair, and radial head replacement. Subsequently, the patient underwent an open capsular release and manipulation of the joint eight month post primary implantation.
 
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Brand NameUNK RADIAL HEAD
Type of DeviceELBOW PROSTHESIS
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 Key9834765
MDR Text Key189769671
Report Number0001825034-2020-01062
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received01/08/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 03/16/2020 Patient Sequence Number: 1
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