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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 5 100 MM LENGTH FOR CEMENTED USE ONLY PROSTHESIS, EXTREMITIES

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ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 5 100 MM LENGTH FOR CEMENTED USE ONLY PROSTHESIS, EXTREMITIES Back to Search Results
Catalog Number 00840004510
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Event Date 08/12/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-03018. Concomitant medical products: item# 00840009000; lot# 63909416, item# 00840001507; lot# 63670155, and item# 00840009500; lot# 63930799. Full establishment name - (b)(6). Foreign - event occurred in uk. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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.
 
Event Description
It was reported that the patient underwent a total elbow arthroplasty in a clinical study approximately two (2) years and five (5) months ago. Subsequently, patient had fallen post-implantation and experienced a peri-prosthetic fracture on an unknown date. Patient was treated with a splint. Approximately two (2) months ago during the patient's two (2) year follow-up appointment, it was noted in the x-rays that the humeral component was loose at the site of the previous peri-prosthetic fracture. There is currently no plan to revise the patient or do further intervention. Attempts have been made and no further information has been provided.
 
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Brand NameHUMERAL COMPONENT PLASMA SPRAYED SIZE 5 100 MM LENGTH FOR CEMENTED USE ONLY
Type of DevicePROSTHESIS, EXTREMITIES
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 Key12704326
MDR Text Key278564187
Report Number0001822565-2021-03016
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K181307
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00840004510
Device Lot Number63691823
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 Received10/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 10/27/2021 Patient Sequence Number: 1
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