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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CONE PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ARCOS CONE PROSTHESIS, HIP Back to Search Results
Catalog Number 11-301311
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Impaired Healing (2378); No Information (3190)
Event Date 10/31/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown. The investigation is in process. Once the investigation is complete a follow-up mdr will be submitted. Device available for evaluation: part # unk/ unk head/ unk lot #, part # unk/ unk cup / unk lot #, part # unk/ unk liner/ unk lot #. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 -05016.
 
Event Description
It was reported that patient underwent a revision surgery on an unknown date for unknown reasons. Stem component was removed. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameARCOS CONE
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 Key9363273
MDR Text Key167758692
Report Number0001825034-2019-05311
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090757
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number11-301311
Device Lot Number869550
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 Received02/05/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 11/22/2019 Patient Sequence Number: 1
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