MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL AMT SZ11 STD COL; CORAIL IMPLANTS : HIP FEMORAL STEM

Catalog Number	L971211
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 there was labelling issue on corail amt where the image on the label didn¿t have a collar on the stem.(b)(4) is linked to the following complaints which capture additional impacted products: (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary according to the information provided: "labelling issue on corail amt where the image on the label didn¿t have a collar on the stem".The product was returned to depuy synthes for evaluation.Visual inspection of the returned device revealed that the outer package label incorrectly displayed a collarless corail stem instead of the collared stem to match the label.The observed condition of the device has been addressed through the depuy synthes quality management system.Assignable cause is determined to be man, investigation point to a label design error when selecting the correct graphic as part of the mdr primary label record (plr) creation process.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the corail amt sz11 std col would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue has been addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot nr was raised to address current complaint condition.H11 additional narrative: added: d4 lot, d9 corrected: d4 primary udi number, h3.

• Brand Name: CORAIL AMT SZ11 STD COL
• Common Device Name: CORAIL IMPLANTS : 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: 23126866
• Report Number: 1818910-2025-16378
• Device Sequence Number: 9352069
• Product Code: MEH
• UDI-Device Identifier: 10603295478621
• UDI-Public: (01)10603295478621(10)4835579
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K213839
• 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,Distributor
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: L971211
• Device Lot Number: 4835579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown