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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A STD 50MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ARCOS CON SZ A STD 50MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Impaired Healing (2378)
Event Date 10/05/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Date of birth: (b)(6). Concomitant medical products: catalog#: ep-200144 act artic e1 hip brg 28x38mm lot#: 645000, catalog#: 110010242 g7 osseoti 3 hole shell 48mm c lot#: 6564825, catalog#: 110024461 g7 dual mobility liner 38mm c lot#: 475980, unknown stem. Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04861, 0001825034-2019-04866, 0001825034-2019-04868, 0001825034-2019-04869.
 
Event Description
It was reported that the patient underwent a wash out of the wound approximately one month post implantation. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameARCOS CON SZ A STD 50MM
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 Key9247704
MDR Text Key164106306
Report Number0001825034-2019-04867
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K090757
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number11-301300
Device Lot Number023440
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 Received03/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2019
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: 10/28/2019 Patient Sequence Number: 1
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