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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM LENGTH ELBOW, PROSTHESIS

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ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM LENGTH ELBOW, PROSTHESIS Back to Search Results
Catalog Number 00840004410
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 09/07/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: foreign: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up report will be submitted.
 
Event Description
It was reported that the patient was revised due to humeral component loosening secondary to a fall and humeral fracture. It was reported that no further information is available.
 
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Brand NameHUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM LENGTH
Type of DeviceELBOW, PROSTHESIS
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 Key12555710
MDR Text Key274066758
Report Number0001822565-2021-02838
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K123862
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 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00840004410
Device Lot Number64363527
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/18/2021
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

Patient Treatment Data
Date Received: 09/30/2021 Patient Sequence Number: 1
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