MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL AMT COLLAR SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92502
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
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.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
It was reported that there was heat damage to plastic container housing corail femoral implant.There was no patient involvement.
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 that 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.H11 additional narrative: added: b5.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received and states that ¿ can you please clarify what do you mean by ¿damaged¿? was it worn, cracked, broken into pieces, bent, stripped, cross threaded or any device interaction.¿ was the procedure completed successfully? yes, other stock available.¿ was there an alternate implant available to complete the procedure? yes.
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 that 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.H11 additional narrative: added: d9.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : heat damage to plastic container housing corail femoral implant.The product was not returned to j&j medtech orthopaedics, however photos were provided for review."a-13648007 source data (b)(4)".The photo investigation revealed that the corail amt collar size 12 blister packaging was deformed/warped.With available information a definitive potential cause can not be established.This product issue will be addressed through j&j medtech orthopaedics quality 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.A search of the j&j medtech orthopaedics nonconformance (nc) quality system was performed for this product/lot combination and three non-conformance were found.However, the non-conformance was not related to the reported failure mode.The overall complaint was confirmed as the observed condition of the corail amt collar size 12 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 j&j medtech orthopaedics 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 search of the j&j medtech orthopaedics nonconformance (nc) quality system was performed for this product/lot combination and three non-conformance were found.However, the non-conformance was not related to the reported failure mode.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : heat damage to plastic container housing corail femoral implant.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.See attachment "a-13648007 source data (b)(4)".The photo investigation revealed that the corail amt collar size 12 blister packaging was deformed/warped.With available information a definitive potential cause can not be established.This product issue will be addressed through j&j medtech orthopaedics quality 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.A search of the j&j medtech orthopaedics nonconformance (nc) quality system was performed for this product/lot combination and three non-conformance were found.However, the non-conformance was not related to the reported failure mode.The overall complaint was confirmed as the observed condition of the corail amt collar size 12 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 j&j medtech orthopaedics 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 search of the j&j medtech orthopaedics nonconformance (nc) quality system was performed for this product/lot combination and three non-conformance were found.However, the non-conformance was not related to the reported failure mode.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : heat damage to plastic container housing corail femoral implant.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the that the corail amt collar size 12 blister packaging was deformed/warped.With available information a definitive potential cause can not be established.This product issue will be addressed through j&j medtech orthopaedics quality 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.A search of the j&j medtech orthopaedics nonconformance (nc) quality system was performed for this product/lot combination and three non-conformance were found.However, the non-conformance was not related to the reported failure mode.The overall complaint was confirmed as the observed condition of the corail amt collar size 12 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 j&j medtech orthopaedics 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 search of the j&j medtech orthopaedics nonconformance (nc) quality system was performed for this product/lot combination and three non-conformance were found.However, the non-conformance was not related to the reported failure mode.Corrected: h3.

• Brand Name: CORAIL AMT COLLAR SIZE 12
• 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: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22749912
• Report Number: 1818910-2025-13905
• Device Sequence Number: 18305574
• Product Code: LZO
• UDI-Device Identifier: 10603295168683
• UDI-Public: (01)10603295168683(17)300430(10)5881426
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,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: 3L92502
• Device Lot Number: 5881426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 08/11/2025; 09/10/2025; 09/29/2025; 10/02/2025; 10/06/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 08/14/2025; 09/11/2025; 09/30/2025; 10/03/2025; 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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