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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK FEMORAL TRIAL; STEM TRIAL
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DEPUY ORTHOPAEDICS INC US UNK FEMORAL TRIAL; STEM TRIAL Back to Search Results
Catalog Number UNK FEMORAL TRIAL
Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 01/01/2020
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
Problem : loose trial head corail result: hard to catch in the wound // one case several years ago , resulted in complication so they have to called in a second surgeon to get out the trial head.( 2017 ).
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand Name
UNK FEMORAL TRIAL
Type of Device
STEM TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10696449
MDR Text Key213675281
Report Number1818910-2020-22683
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 09/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK FEMORAL TRIAL
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/22/2020
Initial Date FDA Received10/19/2020
Supplement Dates Manufacturer Received12/10/2020
Supplement Dates FDA Received12/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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