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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH AVENIR MÜLLER, STEM, LATERAL, UNCEMENTED, HA, 4, TAPER 12/14 AVENIR MULLER STEM

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ZIMMER GMBH AVENIR MÜLLER, STEM, LATERAL, UNCEMENTED, HA, 4, TAPER 12/14 AVENIR MULLER STEM Back to Search Results
Model Number N/A
Device Problem Component Missing
Event Date 11/27/2017
Event Type  Malfunction  
Manufacturer Narrative

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).

 
Event Description

It was reported that during surgery on (b)(6) 2017 the patient labels inside the packaging of an avenir müller, stem, lateral, uncemented, ha, 4, taper 12/14 were missing. It was also reported that the implant was used. No harm or injury to patient was reported.

 
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Brand NameAVENIR MÜLLER, STEM, LATERAL, UNCEMENTED, HA, 4, TAPER 12/14
Type of DeviceAVENIR MULLER 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 Key7141495
Report Number0009613350-2017-01835
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number01.06010.104
Device LOT Number2905496
OTHER Device ID Number00889024479500
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/19/2017
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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