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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH WAGNER CONE PROSTHESIS, TRIAL STEM, DISTAL, 15 WAGNER CONE PROSTHESIS SYSTEM

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ZIMMER GMBH WAGNER CONE PROSTHESIS, TRIAL STEM, DISTAL, 15 WAGNER CONE PROSTHESIS SYSTEM Back to Search Results
Model Number N/A
Device Problem Defective Device
Event Date 06/13/2018
Event Type  Injury  
Manufacturer Narrative

(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. (b)(4). (b)(4).

 
Event Description

It was reported that the surgeon noticed several difficulties using the instrument during the surgery. This caused a delay of 3 hours but however the surgery was completed as planned.

 
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Brand NameWAGNER CONE PROSTHESIS, TRIAL STEM, DISTAL, 15
Type of DeviceWAGNER CONE PROSTHESIS SYSTEM
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 Key7766413
Report Number0009613350-2018-00711
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/09/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number01.00569.115
Device LOT Number16.244393
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 Received11/13/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/15/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 08/09/2018 Patient Sequence Number: 1
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