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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SIGMA HP UNI DISTAL CUT BLOCK KNEE INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS, INC. SIGMA HP UNI DISTAL CUT BLOCK KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 202499007
Device Problem Difficult to Insert (1316)
Patient Problem No Information (3190)
Event Date 05/15/2017
Event Type  malfunction  
Manufacturer Narrative
Examination of the returned device could not replicate the reported event. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event Description
It was reported that the interference fit between the uni distal block and the 1mm shim did not engage.
 
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Brand NameSIGMA HP UNI DISTAL CUT BLOCK
Type of DeviceKNEE INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6636287
MDR Text Key104052568
Report Number1818910-2017-19334
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number202499007
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2017
Was Device Evaluated by Manufacturer? Yes
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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