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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REVISION REAMER 16MM KNEE INSTRUMENT : REAMERS

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DEPUY ORTHOPAEDICS, INC. 1818910 MBT REVISION REAMER 16MM KNEE INSTRUMENT : REAMERS Back to Search Results
Model Number 2178-63-176
Device Problem Device-Device Incompatibility (2919)
Patient Problem Insufficient Information (4580)
Event Date 07/14/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (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 trial will not fit properly on the 45 mm tibia broach. Stem trial will also not fit properly on the 34 mm and the 31 mm femoral broach. 16 mm reamer comes loose from the hudson adapter.
 
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Brand NameMBT REVISION REAMER 16MM
Type of DeviceKNEE INSTRUMENT : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
b.p. 256
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12273607
MDR Text Key264933943
Report Number1818910-2021-16945
Device Sequence Number1
Product Code HTO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2178-63-176
Device Catalogue Number217863176
Device Lot NumberNG76026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2018
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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