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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK VERSA FX PROSTHESIS HIP

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ZIMMER BIOMET, INC. UNK VERSA FX PROSTHESIS HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/23/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (udi): n/a. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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. Location unknown.
 
Event Description
If was reported that the patient underwent right hip arthroplasty on an unknown date. Subsequently, the patient has been revised approximately 2 weeks ago due to degenerative bone disease.
 
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Brand NameUNK VERSA FX
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 Key9678342
MDR Text Key178101043
Report Number0001825034-2020-00527
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2020
Is this an Adverse Event Report? No
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 Received02/26/2020
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
Removal/Correction NumberN/A

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