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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSYS TROCHANTERIC REAMER HIP INSTRUMENT

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ZIMMER BIOMET, INC. VERSYS TROCHANTERIC REAMER HIP INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Device Markings / Labelling Problem
Event Date 01/30/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4) (b)(6). Reporter had indicated that product will be returned. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported by the warehouse technician that the product received had a wrong device corresponding to package labeled.

 
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Brand NameVERSYS TROCHANTERIC REAMER
Type of DeviceHIP INSTRUMENT
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 Key7302254
Report Number0001822565-2018-00978
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup,Followup
Report Date 04/05/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/28/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00789601000
Device LOT Number62736089
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/21/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/19/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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