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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL AMT COLLAR SIZE 8; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US 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 07/02/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).(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 an infection.Doi: (b)(6) 2013.Dor: (b)(6) 2021.Affected side: unknown 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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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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 ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12212247
Report Number1818910-2021-15781
Device Sequence Number14551012
Product Code KWA
UDI-Device Identifier10603295168645
UDI-Public10603295168645
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K070554
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
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) 07/02/2021
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 Health Professional
Device Model Number3L92498
Device Catalogue Number3L92498
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/02/2021
Supplement Date Received by Manufacturer08/26/2021
Initial Report FDA Received Date07/22/2021
Supplement Report FDA Received Date08/27/2021
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 32IDX48OD; CORAIL AMT COLLAR SIZE 8; DLT TS CER HD 12/14 32MM +1; PINN SECTOR W/GRIPTION 48MM; ALTRX NEUT 32IDX48OD; CORAIL AMT COLLAR SIZE 8; DLT TS CER HD 12/14 32MM +1; PINN SECTOR W/GRIPTION 48MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age34 YR
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