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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH ORIGINAL M.E. MULLER, STEM, PT-S30, STRAIGHT, LATERAL, CEMENTED, 10.0, TAPER MULLER STRAIGHT STEM FEMORAL PROSTHESIS

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ZIMMER GMBH ORIGINAL M.E. MULLER, STEM, PT-S30, STRAIGHT, LATERAL, CEMENTED, 10.0, TAPER MULLER STRAIGHT STEM FEMORAL PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Component Missing
Event Date 04/12/2018
Event Type  Malfunction  
Manufacturer Narrative

The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. The device history records were reviewed and found to be conforming. 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 the stickers with reference number and lot were missing inside the box. Attempts to obtain additional information have been made; however, no more is available.

 
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Brand NameORIGINAL M.E. MULLER, STEM, PT-S30, STRAIGHT, LATERAL, CEMENTED, 10.0, TAPER
Type of DeviceMULLER STRAIGHT STEM FEMORAL PROSTHESIS
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 Key7493610
Report Number0009613350-2018-00502
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/24/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/08/2018
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number35.00.39-100
Device LOT Number2935132
OTHER Device ID Number00889024417656
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 Received10/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/19/2018
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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