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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 3; HIP FEMORAL STEM
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DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 3; HIP FEMORAL STEM Back to Search Results
Model Number 1010-12-030
Medical Device Problem Code Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/01/2021
Type of Reportable Event Malfunction
Additional 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 or Problem Description
(b)(4).
 
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Brand Name
ACTIS COLLARED HIGH SIZE 3
Common Device Name
HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11278449
Report Number1818910-2021-02400
Device Sequence Number2590603
Product Code MEH
UDI-Device Identifier10603295380559
UDI-Public10603295380559
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K150862
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 01/19/2021
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
Operator of Device Health Professional
Device Model Number1010-12-030
Device Catalogue Number101012030
Device Lot NumberJ9079K
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/19/2021
Supplement Date Received by Manufacturer04/08/2021
Initial Report FDA Received Date02/04/2021
Supplement Report FDA Received Date04/13/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ACTIS COLLARED HIGH SIZE 3; ATTUNE PS FB INSRT SZ 3 7MM; ATTUNE PS FB INSRT SZ 6 5MM
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