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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COONRAD MORREY HUMERAL IMPLANT PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. UNKNOWN COONRAD MORREY HUMERAL IMPLANT PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown bearing; unknown hinge pin; unknown ulnar component. Report source: foreign country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported patient underwent elbow arthroplasty on unknown date. Subsequently, the patient suffered fracture of the humeral component after suffering from trauma. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN COONRAD MORREY HUMERAL IMPLANT
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 Key12605619
MDR Text Key275874159
Report Number0001822565-2021-02933
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/04/2021
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
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 10/11/2021 Patient Sequence Number: 1
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