MAUDE Adverse Event Report: DEPUY IRELAND 9616671 CORAIL AMT COLLAR SIZE 18; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L92508
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2021
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
The reason for revision was due to surgeon error in incorrectly positioning the stem through the femur.There are no x-rays and no other data will be provided by the revising surgeon.The revising surgeon does not require any follow up.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Based on the provided information the root cause is attributed to inadvertent use error.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.

• Brand Name: CORAIL AMT COLLAR SIZE 18
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 11377780
• Report Number: 1818910-2021-03825
• Device Sequence Number: 17087385
• Product Code: LZO
• UDI-Device Identifier: 10603295168744
• UDI-Public: 10603295168744
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 02/11/2021

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 Expiration Date: 04/30/2024
• Device Model Number: 3L92508
• Device Catalogue Number: 3L92508
• Device Lot Number: 5344676
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 28 +1.5 GR; CORAIL AMT COLLAR SIZE 18; PINN CAN BONE SCREW 6.5MMX25MM; PINN MAR NEUT 28IDX60OD; PINN MULTIHOLE W/GRIPTION 60MM; ARTICUL/EZE BALL 28 +1.5 GR; CORAIL AMT COLLAR SIZE 18; PINN CAN BONE SCREW 6.5MMX25MM; PINN MAR NEUT 28IDX60OD; PINN MULTIHOLE W/GRIPTION 60MM
• Outcome Attributed to Adverse Event: Required Intervention