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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 CORAIL AMT COLLAR SIZE 8; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
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DEPUY IRELAND 9616671 CORAIL AMT COLLAR SIZE 8; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM Back to Search Results
Model Number 3L92498
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 02/25/2021
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 had an infected hip.All components were removed and an antibiotic spacer was placed.Doi: (b)(6) 2018, dor: (b)(6) 2021, 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 sterile processing, manufacturing or material 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
CORAIL AMT COLLAR SIZE 8
Common Device Name
CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
MDR Report Key11437236
Report Number1818910-2021-04622
Device Sequence Number3976731
Product Code KWA
UDI-Device Identifier10603295168645
UDI-Public10603295168645
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K070554
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
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) 02/25/2021
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? No
Operator of Device No Information
Device Model Number3L92498
Device Catalogue Number3L92498
Device Lot Number5314292
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/25/2021
Supplement Date Received by Manufacturer04/07/2021
Initial Report FDA Received Date03/08/2021
Supplement Report FDA Received Date04/08/2021
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
ALTRX NEUT 32IDX50OD; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +1 GR; CORAIL AMT COLLAR SIZE 8; PINN CAN BONE SCREW 6.5MMX20MM; PINN SECTOR W/GRIPTION 50MM; ALTRX NEUT 32IDX50OD; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +1 GR; CORAIL AMT COLLAR SIZE 8; PINN CAN BONE SCREW 6.5MMX20MM; PINN SECTOR W/GRIPTION 50MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age53 YR
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