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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. C/M HUMERAL ASSEMBLY 6IN SMALL PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. C/M HUMERAL ASSEMBLY 6IN SMALL PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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. Medical devices: part # unk, ulnar component, lot # unk; 00-1119-140-01, palacos lvg 1x40 single, lot # 75394316; 32-8105-025-01, cm pinbush replace. Kit smlreg, lot # 62354122. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 07063.
 
Event Description
It was reported that approximately 5 years post implantation, the patient has been indicated for a revision of the humeral and ulnar components due to unknown reasons with the current information provided. Attempts have been made and no further information has been provided.
 
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Brand NameC/M HUMERAL ASSEMBLY 6IN SMALL
Type of DevicePROSTHESIS, ELBOW
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 Key8204672
MDR Text Key131697719
Report Number0001822565-2018-07062
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001989
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 03/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2017
Device Model NumberN/A
Device Catalogue Number32810502506
Device Lot Number62196127
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 Received03/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/28/2018 Patient Sequence Number: 1
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