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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET UNKNOWN E1 MAXROM LINER PROSTHESIS, HIP

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ZIMMER BIOMET, INC. BIOMET UNKNOWN E1 MAXROM LINER PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Hematoma (1884)
Event Date 02/14/2011
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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. Unique identifier (udi) #: n/a. Concomitant medical products: item # unk , stem, lot # unk; item # 157454, head, lot # unk; item # unk, shell, lot # unk. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-05655, 0001825034-2018-05656, 0001825034-2018-05657.
 
Event Description
It was reported that approximately 3 weeks post implantation, the patient underwent an i&d of a hematoma with positive cultures. Attempts have been made and no further information has been provided.
 
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Brand NameBIOMET UNKNOWN E1 MAXROM LINER
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 Key7761756
MDR Text Key116389026
Report Number0001825034-2018-05658
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
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 Received05/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/08/2018 Patient Sequence Number: 1
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