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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 7; HIP FEMORAL STEM
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DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 7; HIP FEMORAL STEM Back to Search Results
Model Number 1010-11-070
Device Problem Malposition of Device (2616)
Patient Problem No Code Available (3191)
Event Date 05/11/2020
Event Type  Injury  
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
The patient was revised to address bad version.Doi: (b)(6) 2020.Dor: (b)(6) 2020.Left side.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
 
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Brand Name
ACTIS COLLARED STD SIZE 7
Type of Device
HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10080695
MDR Text Key191759812
Report Number1818910-2020-12471
Device Sequence Number1
Product Code KWL
UDI-Device Identifier10603295380474
UDI-Public10603295380474
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1010-11-070
Device Catalogue Number101011070
Was Device Available for Evaluation? No
Date Manufacturer Received07/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DELTA CER HEAD 12/14 36MM +5; DELTA CER HEAD 12/14 36MM +5
Patient Outcome(s) Required Intervention;
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