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	Insufficient Information (4580)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product package is damaged.In pictures looks like shipping box is fine, product package damaged.
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.
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.H10 additional narrative: corrected: b3.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: information from customer service: damaged package, in pictures looks like shipping box is fine, product package damaged.The product was not returned to depuy synthes, however photos were provided for review.See attachment [img_4281, img_4282].The photo investigation revealed that the outer packaging was damaged, the film and cardboard of the box was punctured, confirming the reported allegation.It is suspected that main cause for this type of damage could be for transport/storage, however a rood cause cannot be determined.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 collar size 12 would contribute to the complained device issue.Based on the investigation findings, the potential cause is not established, and 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: corail amt collar size 12 product code: 3l92502 lot number: 5680326 and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: corail amt collar size 12 product code: 3l92502 lot number: 5680326 and no non-conformances or manufacturing irregularities were identified.
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.H11 additional narrative: added: d9.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 : information from customer service: damaged package, in pictures looks like shipping box is fine, product package damaged.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the outer packaging was damaged, the film and cardboard of the box was punctured, confirming the reported allegation.It is suspected that main cause for this type of damage could be for transport/storage, however a rood cause cannot be determined.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 collar size 12 would contribute to the complained device issue.Based on the investigation findings, the potential cause is not established, and 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: corail amt collar size 12 product code: 3l92502 lot number: 5680326 and no non-conformances or manufacturing irregularities were identified.Device history review : a manufacturing record evaluation was performed for the finished device product description: corail amt collar size 12 product code: 3l92502 lot number: 5680326 and no non-conformances or manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: information from customer service: damaged package, in pictures looks like shipping box is fine, product package damaged.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device found that the outer implant box was perforated with a small visible hole on the front side.Additionally the shrink-wrap plastic was damaged.The potential cause of the observed complaint condition cannot be traced to a manufacturing issue.Once the product leaves j&j medtech orthopaedics control, it is unknown what environment conditions or human intervention or manipulation the packaged products are exposed to during that time.Therefore the suspected cause is traced to transport/storage outside of j&j medtech orthopaedics control.A manufacturing record evaluation was performed for the finished device product description: corail amt collar size 12 product code: 3l92502 lot number: 5680326 and no non-conformances or manufacturing irregularities were identified.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 collar size 12 would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to transport/storage, and 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 manufacturing record evaluation was performed for the finished device product description: corail amt collar size 12 product code: 3l92502 lot number: 5680326 and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: corail amt collar size 12 product code: 3l92502 lot number: 5680326 and no non-conformances or manufacturing irregularities were identified.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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19276944
• Report Number: 1818910-2024-10217
• Device Sequence Number: 18040539
• Product Code: LZO
• UDI-Device Identifier: 10603295168683
• UDI-Public: 10603295168683
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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
• Report Date (Section B): 05/09/2024

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: LOT 5680326
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 05/14/2024; 05/29/2024; 06/12/2025; 06/18/2025; 06/30/2025
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/16/2024; 05/29/2024; 06/13/2025; 06/19/2025; 07/01/2025
• 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