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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 18X150MM SPL TPR DIST PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ARCOS 18X150MM SPL TPR DIST PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Blood Loss (2597)
Event Date 02/07/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr's were reported for this event. Please also see associated events: 0001825034 - 2018 - 02857, 0001825034 - 2018 - 02859. Concomitant medical products: 11-301300 arcos con sz a std 50mm lot 712270, 11-363660 36mm cocr mod hd -6mm lot 279730. Reported event was confirmed with review of medical records received from the customer. Device history record was reviewed and no discrepancies were found. Root cause was unable to be determined. 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. Not returned to manufacturer.
 
Event Description
It was reported that there was wound dehiscence with uncontrolled bleeding. Attempts have been made and no further information has been made available at this time.
 
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Brand NameARCOS 18X150MM SPL TPR DIST
Type of DevicePROSTHESIS, HIP
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 Key7448421
MDR Text Key106137221
Report Number0001825034-2018-02858
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK090757
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number11-300818
Device Lot Number140030
Other Device ID Number(01) 00880304474147
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2015
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: 04/20/2018 Patient Sequence Number: 1
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