MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 NON COL HO SIZE 9; HIP FEMORAL STEM

Catalog Number	L20309
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stem was loose and came out easily.
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.H11 additional manufacturer narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary doctor informed that the stem was loose and came out easily.The product was not returned to depuy synthes, however photos were provided for review.The photo and x-ray investigation revealed radiolucency gaps around the device indicating lack of proper bone ingrowth to the fixation surface additionally minor signs of organic material, likely indicating poor bone ingrowth adhered to the fixation surface, with this condition it is reasonable to confirm loosening at the corail2 non col ho size 9.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.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.A manufacturing record evaluation was performed for the finished device product description: corail2 non col ho size 9 product code: l20309 lot number: 5412564 and no non-conformances or manufacturing irregularities were identified.The overall complaint was confirmed as the observed condition of the corail2 non col ho size 9 would have contributed to the complained 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 non col ho size 9 product code: l20309 lot number: 5412564 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 non col ho size 9 product code: l20309 lot number: 5412564 and no non-conformances or manufacturing irregularities were identified.Added: d4 (lot, expiration), h4.Corrected: e1, d4 (primary udi #.

• Brand Name: CORAIL2 NON COL HO SIZE 9
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23646855
• Report Number: 1818910-2025-20743
• Device Sequence Number: 20039696
• Product Code: LZO
• UDI-Device Identifier: 10603295258001
• UDI-Public: (01)10603295258001(17)270331(10)5412564
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: IN
• 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

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 Catalogue Number: L20309
• Device Lot Number: 5412564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2022
• 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