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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISC HUM 6X100MM RT FLANGED C PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. DISC HUM 6X100MM RT FLANGED C PROSTHESIS, ELBOW Back to Search Results
Model Number 114909
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/27/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Foreign- (b)(6). Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. 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. Device has been discarded.
 
Event Description
It was reported that the patient underwent a revision procedure approximately five years post initial implantation due to the loosening of the humeral component. No additional patient consequences were reported.
 
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Brand NameDISC HUM 6X100MM RT FLANGED C
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 Key11309590
MDR Text Key231311156
Report Number0001825034-2021-00434
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K013042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number114909
Device Catalogue Number114909
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 Received01/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/10/2021 Patient Sequence Number: 1
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