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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULATION KIT SIZE 4 PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. ARTICULATION KIT SIZE 4 PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problems Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Associated item number 00-0084-090-00, item name, screw kit, lot #unk. Associated item number 00-8400-044-10, item name, humeral-stem-sz4-100mm, lot #unk. Associated item number 00-8400-024-07, item name, ulnar-stem-sz4-75mm-rt, lot #unk. (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device remains implanted.
 
Event Description
The surgeon reported the coupling mechanism had no play during implantation and took strength to insert. The device was successfully implanted in the patient without significant delay or adverse consequence to the patient. No further information is available.
 
Event Description
The surgeon reported the coupling mechanism had no play during implantation and took strength to insert. A second articulation kit and screws were opened and attempted for use, however the same issue occurred. The device was successfully implanted in the patient without significant delay or adverse consequence to the patient. No further information is available.
 
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Brand NameARTICULATION KIT SIZE 4
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 Key7999809
MDR Text Key124832648
Report Number0001822565-2018-05868
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00840009400
Device Lot Number63943945
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 Received11/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2018
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

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