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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH AVENIR, STEM, STANDARD, CEMENTED, 2, TAPER 12/14 AVENIR CEMENTED HIP STEM

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ZIMMER GMBH AVENIR, STEM, STANDARD, CEMENTED, 2, TAPER 12/14 AVENIR CEMENTED HIP STEM Back to Search Results
Model Number N/A
Device Problem Incomplete or Missing Packaging
Event Date 10/09/2018
Event Type  Malfunction  
Manufacturer Narrative

Model #/lot # - additional device information: unique identifier (udi) # (b)(4). The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. The device history records were reviewed and found to be conforming. Additional information has been requested and is currently not available. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available, an updated report will be submitted. Zimmer biomet¿s reference number of this file is (b)(4).

 
Event Description

It was reported that during a surgery, it was noticed that the patient label was missing.

 
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Brand NameAVENIR, STEM, STANDARD, CEMENTED, 2, TAPER 12/14
Type of DeviceAVENIR CEMENTED HIP STEM
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
Manufacturer (Section G)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key8019221
Report Number0009613350-2018-01112
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/08/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2018
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue Number01.06010.202
Device LOT Number2956568
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 Received12/12/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/25/2018
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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