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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLA REAMER BLADE WITH PILOT HOLE 41 MM DIAMETER SINGLE USE ONLY PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PATELLA REAMER BLADE WITH PILOT HOLE 41 MM DIAMETER SINGLE USE ONLY PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Misassembled During Installation
Event Date 10/05/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Concomitant medical products: patella reamer surfacing guide, catalog number: 00512007141, lot number: unknown. Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported during a knee arthroplasty, the instrument would not assemble to the reamer guide. Subsequently, another instrument was used to complete the procedure. Attempts have been made and additional information on the reported event is unavailable. No adverse events have been reported as a result of the malfunction.

 
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Brand NamePATELLA REAMER BLADE WITH PILOT HOLE 41 MM DIAMETER SINGLE USE ONLY
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key8045987
Report Number0001822565-2018-06173
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/07/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00597909541
Device LOT Number64018810
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/14/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/08/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/27/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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