MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL2 STD SIZE 11; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92511
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Early loosening of the corail stem.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Corrected: h3.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: early loosening of the corail stem.The product was returned to depuy synthes for evaluation.Visual analysis of the returned device revealed minor signs of organic material, likely indicating bone ingrowth adhered to the fixation surface.Additionally, light marks were observed on the neck surface, most likely caused by the explantation process.The device still retains some hydroxyapatite that was not absorbed by the patient.Poor hydroxyapatite absorption might suggest improper fixation between the bone and the implant.However, without the implantation date, it is impossible to determine if there was sufficient time for the implant to properly integrate with the bone.Further considerations must include potential influences such as the surgical process, patient variables (e.G., activity level, use, bone quality), anatomical factors, and changes in the patient over time.Any conclusions from the provided investigational input must be contextualized with all other relevant factors.With the current evidence, it is not possible to confirm the reported loosening condition of the corail2 std size 11.A dimensional inspection and functional testing were not performed since it was not applicable to the complaint condition.A manufacturing record evaluation was performed for the finished device product description: corail2 std size 11 product code: 3l92511 lot number: 5290342 and no non-conformances or manufacturing irregularities were identified.The overall complaint was not confirmed as the observed condition of the corail2 std size 11 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 was performed for the finished device product description: corail2 std size 11 product code: 3l92511 lot number: 5290342 and no non-conformances or manufacturing irregularities were identified.Device history review = > a manufacturing record evaluation was performed for the finished device product description: corail2 std size 11 product code: 3l92511 lot number: 5290342 and no non-conformances or manufacturing irregularities were identified.

• Brand Name: CORAIL2 STD SIZE 11
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19191225
• Report Number: 1818910-2024-09211
• Device Sequence Number: 8474294
• Product Code: LZO
• UDI-Device Identifier: 10603295168775
• UDI-Public: (01)10603295168775(17)220228(10)5290342
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 04/26/2024

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: 02/28/2022
• Device Catalogue Number: 3L92511
• Device Lot Number: 5290342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 06/17/2024; 07/11/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 06/17/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2017
• 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 Sex: Unknown