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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 13X145MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 13X145MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)
Event Date 06/05/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). D. O. B: unknown month and day in (b)(6). Concomitant medical devices: catalog#: 010000663 g7 pps ltd acet shell 52e lot#: 6320647; catalog#: 650-1162 delta cer fem hd 32/0mm t1 lot#: 2018080547; catalog#: 110003626 biolox delta cer lnr 32mm e lot#: 3745537. Foreign: (b)(6). At this time, it is unknown if the device will be returned for evaluation, due to location of device is unknown; however, an investigation of the reported event is in progress. 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: 0001825034-2021-00352.
 
Event Description
It was reported that approximately one month post implantation, the patient experienced a superficial skin infection. The infection was resolved with medication. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameECHO POR FMRL LAT NC 13X145MM
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 Key11280832
MDR Text Key230460099
Report Number0001825034-2021-00351
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K070274
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 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number192113
Device Lot Number147410
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 Received02/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/04/2021 Patient Sequence Number: 1
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