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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.
 
Manufacturer Narrative
Multiple mdr's were filed for this event. Please see associated report(s): 0001822565 - 2018 - 06659. Udi# (b)(4). Concomitant medical products: 00840009400 articulation kit lot# 63916386, 00840004410 humeral component plasma sprayed size 4 100 mm length for cemented use only lot # 63965679, 00840002407 ulnar component plasma sprayed size 4 75 mm length right for cemented use only lot # 64006186, 00840009000 humeral screw kit 2 humeral screws lot # 64040980, 00840009000 humeral screw kit 2 humeral screws lot # 64040980. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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.
 
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
MDR Report Key7999809
MDR Text Key124832648
Report Number0001822565-2018-05868
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
K123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
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
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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