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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 INSTRUMENTATION, KNEE

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ZIMMER BIOMET, INC. PATELLA REAMER BLADE WITH PILOT HOLE INSTRUMENTATION, KNEE Back to Search Results
Catalog Number 00597909529
Device Problem Difficult to Insert
Event Date 03/14/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). (b)(6). The complaint device has not been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch 3500a will be submitted. Discarded.

 
Event Description

It was reported during a knee procedure, the patella reaming blade would not assemble with the reamer blade. Ultimately, a new blade 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
Type of DeviceINSTRUMENTATION, 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 Key8500542
Report Number0001822565-2019-01358
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/27/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/10/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00597909529
Device LOT Number64264664
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 Received11/27/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/14/2019
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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