MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 STD SIZE 8; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92507
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Inadequate Osseointegration (2646); Limb Fracture (4518)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary procedure at another hospital, unable to get accurate surgery date.Patient had a fall, she had a periprosthetic fracture which was treated conservatively.She has been experiencing pain and this is believed to be due to the stem now being loose within the femur.Revision surgery carried out with size 8 ks corail stem removed using a xtraction bolt and slap hammer, didn¿t need to use long k-wires or flexible osteotomes to undermine any fixation.Femur was then prepped and replaced with corail revision stem size 10 standard.Primary ceramic liner replaced with pinnacle dual mobility liner, cup remained insitu.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : primary procedure in [year] at another hospital, unable to get accurate surgery date.Patient had a fall whilst on holiday overseas in [year], she had a periprosthetic fracture which was treated conservatively.She has been experiencing pain and this is believed to be due to the stem now being loose within the femur.Revision surgery carried out with size 8 ks corail stem removed using a xtraction bolt and slap hammer, didn¿t need to use long k-wires or flexible osteotomes to undermine any fixation.Femur was then prepped and replaced with corail revision stem size 10 standard.Primary ceramic liner replaced with pinnacle dual mobility liner, cup remained insitu.The product was not returned to depuy synthes, however photos were provided for review.Visual analysis of the photo revealed that there was no damage or defects with the corail2 std size 8.The image quality is poor and no observations pertaining to the nature of the reported event could be identified.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the corail2 std size 8 would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing record evaluation (nc search) was performed for the finished device product code 3l92507, lot number- 5032912 , and no non-conformances / manufacturing irregularities were identified.

• Brand Name: CORAIL2 STD 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
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19332787
• Report Number: 1818910-2024-10819
• Device Sequence Number: 3076575
• Product Code: LZO
• UDI-Device Identifier: 10603295168737
• UDI-Public: 10603295168737
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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: 04/01/2015
• Device Catalogue Number: 3L92507
• Device Lot Number: 5032912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 79 KG