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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK C-M ULNAR COMPONENT PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. UNK C-M ULNAR COMPONENT PROSTHESIS, ELBOW Back to Search Results
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Foreign report source: (b)(6). The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
In a journal article published approximately one year ago, studying total elbow arthroplasty survivorship for arthritic patients under 55 years old, it was reported that 1 of 19 patients underwent a r ulnar revision due to aseptic loosening. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNK C-M ULNAR COMPONENT
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 Key10098637
MDR Text Key195003269
Report Number0001822565-2020-01891
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received06/10/2020
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: 05/28/2020 Patient Sequence Number: 1
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