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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 65, TAPER 12/14

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ZIMMER GMBH REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 65, TAPER 12/14 Back to Search Results
Model Number N/A
Device Problem Disassembly (1168)
Patient Problem No Information (3190)
Event Date 01/16/2018
Event Type  Injury  
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. X-ray was received and will be part of ongoing investigation. 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). Note: first revision case (cls stem): (b)(4). Implant date taken from second revision case (stem generic): (b)(4). Warsaw complaint was captured under : (b)(4).

 
Event Description

It was reported that the patient had a revision surgery approximately eleven years post implantation due to proximal part disassociated from stem. Attempts to obtain additional information have been made; however, no more is available.

 
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Brand NameREVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 65, TAPER 12/14
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 Key7265964
MDR Text Key99883121
Report Number0009613350-2018-00243
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeNZ
PMA/PMN NumberPN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2012
Device MODEL NumberN/A
Device Catalogue Number01.00402.065
Device LOT Number2393561
OTHER Device ID Number00889024503014
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/25/2007
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

Patient TREATMENT DATA
Date Received: 02/13/2018 Patient Sequence Number: 1
Treatment
ECHO B-MTRC, ITEM# 192807, LOT# 2391876; REVITAN DISTAL, ITEM# 0100405118, LOT# 2383693
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