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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLA REAMER BLADE PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PATELLA REAMER BLADE PROSTHESIS, KNEE Back to Search Results
Catalog Number 00597909546
Device Problem Difficult to Insert
Event Date 02/07/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Concomitant medical products: patella reamer shaft, catalog # 00512007746, lot # 52031800. Report source: foreign source - (b)(6). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that the instrument would not assemble with the mating instrument during a total knee arthroplasty. 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
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 Key8412748
Report Number0001822565-2019-01072
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/13/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/12/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00597909546
Device LOT Number63931521
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/26/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/09/2018
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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