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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
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Codes Fall (1848); Inadequate Osseointegration (2646); Limb Fracture (4518)
Date of Event 04/06/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
It was reported as actis stem, head, bipolar revised for periprosthetic fracture following patient fall.It was also indicated that there was loosening of the stem at the bone to implant interface.Doi: (b)(6) 2021.Dor: (b)(6) 2021.Affected side: left hip.
 
Additional 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, 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.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ACTIS COLLARED STD SIZE 8
Common Device Name
HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11699757
Report Number1818910-2021-08380
Device Sequence Number19741486
Product Code MEH
UDI-Device Identifier10603295380481
UDI-Public10603295380481
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K150862
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/06/2021
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? Yes
Operator of Device Health Professional
Device Model Number1010-11-080
Device Catalogue Number101011080
Device Lot NumberJ5613Y
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/06/2021
Supplement Date Received by Manufacturer05/18/2021
Initial Report FDA Received Date04/21/2021
Supplement Report FDA Received Date05/18/2021
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 STD SIZE 8; ARTICUL/EZE BALL 28 +5 BR; SELF CENT HIP 50X28 BRN; ACTIS COLLARED STD SIZE 8; ARTICUL/EZE BALL 28 +5 BR; SELF CENT HIP 50X28 BRN
Outcome Attributed to Adverse Event Required Intervention;
Patient Age76 YR
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