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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULATION KIT SIZE 4 PROSTHESIS, EXTREMITY

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ZIMMER BIOMET, INC. ARTICULATION KIT SIZE 4 PROSTHESIS, EXTREMITY Back to Search Results
Catalog Number 00840009400
Device Problem Insufficient Information (3190)
Patient Problems Fistula (1862); Unspecified Infection (1930)
Event Date 01/28/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr's were filed for this event. Please see associated report(s): 0001822565 - 2019 - 02069 0001822565 - 2019 - 02070 0001822565 - 2019 - 02071 0001822565 - 2019 - 02073 concomitant medical products: primary di# 00889024271357 part 00840004415 lot 62743884, humeral component, primary di# 00889024271449 part 00840009000 lot 63969924, humeral screws, primary di# 00889024271289 part 00840002407 lot 63383785, ulnar component , primary di# 00889024271456 part 00840009400 lot 64013629, articulation kit. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Remains implanted.
 
Event Description
It was reported the patient underwent i&d due to fistulae, a superficial infection was noted less than one year post primary implantation. No further information available at this time.
 
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Brand NameARTICULATION KIT SIZE 4
Type of DevicePROSTHESIS, EXTREMITY
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 Key8628104
MDR Text Key145648889
Report Number0001822565-2019-02073
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number00840009400
Device Lot Number64013629
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 Received05/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2018
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: 05/21/2019 Patient Sequence Number: 1
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