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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLA REAMING SYSTEM PATELLA REAMER BLADE WITH PILOT HOLE INSTRUMENATATION

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ZIMMER BIOMET, INC. PATELLA REAMING SYSTEM PATELLA REAMER BLADE WITH PILOT HOLE INSTRUMENATATION Back to Search Results
Model Number N/A
Device Problems Positioning Failure ; Difficult to Insert
Event Date 11/20/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Foreign - (b)(6). 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. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.

 
Event Description

It was reported that a new 41mm patella reamer blade didn't fit with reamer guide during a total knee arthroplasty. Subsequently, a 46mm reamer blade was alternatively used to complete the procedure.

 
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Brand NamePATELLA REAMING SYSTEM PATELLA REAMER BLADE WITH PILOT HOLE
Type of DeviceINSTRUMENATATION
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 Key8174899
Report Number0001822565-2018-06915
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/18/2018
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 Number64093400
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/13/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/17/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/09/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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