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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 8 HIP FEMORAL STEM
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DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 8 HIP FEMORAL STEM Back to Search Results
Model Number 1010-11-080
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 06/23/2021
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 surgeon states that the 2 implants were out of spec. Doi: (b)(6) 2021: dor: (b)(6) 2021: hip unknown.
 
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Brand NameACTIS COLLARED STD SIZE 8
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY IRELAND - 9616671
loughbeg, ringaskiddy co
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12180692
MDR Text Key261932480
Report Number1818910-2021-15377
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150862
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
Report Date 06/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1010-11-080
Device Catalogue Number101011080
Device Lot NumberJ99A67
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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