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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PLATE PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. UNKNOWN PLATE PROSTHESIS, ELBOW Back to Search Results
Catalog Number UNKNOWN
Device Problem Malposition of Device (2616)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)
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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02725.
 
Event Description
It was reported that the patient underwent an initial left elbow procedure, subsequently, the patient is being considered for revision due to malalignment of the distal humerus with advanced degeneration of the elbow after multiple osteosyntheses of a distal humerus fracture. No additional patient consequences were reported.
 
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Brand NameUNKNOWN PLATE
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 Key12532629
MDR Text Key273340406
Report Number0001825034-2021-02724
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 09/27/2021 Patient Sequence Number: 1
Treatment
UNKNOWN SCREWS
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