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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 2; HIP FEMORAL STEM
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DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 2; HIP FEMORAL STEM Back to Search Results
Model Number 1010-11-020
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); No Code Available (3191)
Date of Event 09/30/2020
Type of Reportable Event Serious Injury
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
It was reported that the patient developed gram negative bacterial infection.All implants removed and antibiotic spacer implanted.Enclosed is all the info i have for this patient.No surgical delay.Doi: (b)(6) 2020; dor: (b)(6) 2020; left hip.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A singular paper copied x-ray image has been provided for review.Nothing to suggest a product problem or to identify a root cause for the reported infection is identified.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, 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 2
Common Device Name
HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10684080
Report Number1818910-2020-22382
Device Sequence Number16925068
Product Code LZO
UDI-Device Identifier10603295380429
UDI-Public10603295380429
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
K071830
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number1010-11-020
Device Catalogue Number101011020
Device Lot NumberJ09W49
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/30/2020
Supplement Date Received by Manufacturer11/12/2020
Initial Report FDA Received Date10/15/2020
Supplement Report FDA Received Date11/13/2020
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 STD SIZE 2; ALTRX +4 NEUT 32IDX54OD; DLT TS CER HD 12/14 32MM +5; PINN SECTOR W/GRIPTION 54MM; ACTIS COLLARED STD SIZE 2; ALTRX +4 NEUT 32IDX54OD; DLT TS CER HD 12/14 32MM +5; PINN SECTOR W/GRIPTION 54MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age43 YR
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