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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODIFIED HUDSON ADAPTER KNEE INSTRUMENT : ADAPTORS

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DEPUY ORTHOPAEDICS INC US MODIFIED HUDSON ADAPTER KNEE INSTRUMENT : ADAPTORS Back to Search Results
Catalog Number 217863136
Device Problem Appropriate Term/Code Not Available
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. Investigation summary: examination and functional evaluation of the returned device could not replicate the reported event. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

 
Event Description

Modified hudson adapter got stuck on one of the mbt reamers.

 
Manufacturer Narrative

Product complaint #: (b)(4). Investigation summary: examination and functional evaluation of the returned device could not replicate the reported event. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

 
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Brand NameMODIFIED HUDSON ADAPTER
Type of DeviceKNEE INSTRUMENT : ADAPTORS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw , IN 46581-0988
5743725905
MDR Report Key7823692
Report Number1818910-2018-67947
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/07/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/28/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number217863136
Device LOT NumberTBJGF
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/23/2015
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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