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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLA REAMER BLADE 26MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PATELLA REAMER BLADE 26MM PROSTHESIS, KNEE Back to Search Results
Catalog Number 00597909526
Device Problem Difficult to Insert
Event Date 11/08/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Foreign source- (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation is completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that the patella reamer blade would not assemble with the mating instrument. No adverse events have been reported as a result of the malfunction.

 
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Brand NamePATELLA REAMER BLADE 26MM
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 Key8218367
Report Number0001822565-2018-07088
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00597909526
Device LOT Number63980089
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 Received09/23/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/30/2018
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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