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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the picture on l971211 shows a collarless stem, whereas it should show a collared stem as per the l971214 example.
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: h3, h6: the product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation 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 j&j medtech orthopedic quality management system.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 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 label issue was identified during the investigation.This product issue will be addressed through j&j medtech orthopaedics quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: basic question is ¿what is in the box¿ as the picture on l971211 shows a collarless stem, whereas it should show a collared stem as per the l971214 example.I¿ve not asked for any other checks to be performed.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment (b)(4) external re corail collared.The photo investigation 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 j&j medtech orthopedic quality management system.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 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 label issue was identified during the investigation.This product issue will be addressed through j&j medtech orthopaedics 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: d9.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: basic question is ¿what is in the box¿ as the picture on l971211 shows a collarless stem, whereas it should show a collared stem as per the l971214 example.I¿ve not asked for any other checks to be performed.The product was returned to j&j medtech orthopaedics 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 j&j medtech orthopedic quality management system.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection 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 will be addressed through j&j medtech orthopaedics 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: corrected: 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: 22532553
• Report Number: 1818910-2025-12388
• Device Sequence Number: 15408607
• Product Code: MEH
• UDI-Device Identifier: 10603295478621
• UDI-Public: (01)10603295478621(17)350531(10)4835580
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 4835580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 09/01/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 07/23/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2025
• 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