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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REV TAPERD PRESSFIT REAMER KNEE INSTRUMENT : REAMERS

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DEPUY ORTHOPAEDICS, INC. 1818910 MBT REV TAPERD PRESSFIT REAMER KNEE INSTRUMENT : REAMERS Back to Search Results
Catalog Number 217863104
Device Problems Difficult to Remove; Device-Device Incompatibility; Physical Resistance/Sticking
Event Date 07/08/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

It was reported that the stem would not seat in either reamer. Stem also became stuck in reamer. No surgical delay.

 
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Brand NameMBT REV TAPERD PRESSFIT REAMER
Type of DeviceKNEE INSTRUMENT : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 19380-0988
6103142063
MDR Report Key8826308
Report Number1818910-2019-99218
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 07/08/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/25/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number217863104
Device LOT NumberA1204
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/15/2004
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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