MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L93712
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.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: damage to plastic packaging on product, outer packaging without damage (does not have picture), no impact on patient, not shipped to any hospital/customer from distributor's warehouse.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the plastic film is torn on the front, by the tear shape at the bottom left side, it appears that the film was in contact with another sharp object.A manufacturing record evaluation was performed for the finished device product code: 3l93712 lot number: 5826417, and no non-conformances or manufacturing irregularities were identified.Evidence indicates that the device had been properly sealed and packaged at the manufacturer.Consequently, there is no indication of any manufacturing error that could have contributed to the reported 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 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 corail2 lat coxa vara size 12 would have contributed to the complained device 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 code: 3l93712 lot number: 5826417, and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product code: 3l93712 lot number: 5826417, and no non-conformances or manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary damage to plastic packaging on product outer packaging without damage (does not have picture) no impact on patient not shipped to any hospital/customer from distributor's warehouse the product was not returned to j&j medtech orthopaedics, however photos were provided for review.See attachment img_1233.Jpg, img_1232.Jpg the photo investigation revealed that the plastic film is torn on the front, by the tear shape at the bottom left side, it appears that the film was in contact with another sharp object.A manufacturing record evaluation was performed for the finished device product code: 3l93712 lot number: 5826417, and no non-conformances or manufacturing irregularities were identified.Evidence indicates that the device had been properly sealed and packaged at the manufacturer.Consequently, there is no indication of any manufacturing error that could have contributed to the reported 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.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 corail2 lat coxa vara size 12 would have contributed to the complained device 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 code: 3l93712 lot number: 5826417, and no non-conformances or manufacturing irregularities were identified.Device history review a manufacturing record evaluation was performed for the finished device product code: 3l93712 lot number: 5826417, and no non-conformances or manufacturing irregularities were identified.
Event or Problem Description
It was reported there was damage to plastic packaging on product.Outer packaging without damage.No impact on patient.
Additional Manufacturer Narrative
Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.Additional narrative: the product was not returned to j&j medtech orthopaedics; however photos were provided for review.The photo investigation revealed that the plastic film is torn on the front, by the tear shape at the bottom left side, it appears that the film was in contact with another sharp object.A manufacturing record evaluation was performed for the finished device product code: 3l93712, lot number: 5826417, and no non-conformances or manufacturing irregularities were identified.Evidence indicates that the device had been properly sealed and packaged at the manufacturer.Consequently, there is no indication of any manufacturing error that could have contributed to the reported 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.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 corail2 lat coxa vara size 12 would have contributed to the complained device 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 a manufacturing record evaluation was performed for the finished device product code: 3l93712, lot number: 5826417, and no non-conformances or manufacturing irregularities were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 12
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21472179
• Report Number: 1818910-2025-03118
• Device Sequence Number: 12967181
• Product Code: LZO
• UDI-Device Identifier: 10603295168898
• UDI-Public: (01)10603295168898(17)291130(10)5826417
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 3L93712
• Device Lot Number: 5826417
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 03/06/2025; 03/07/2025; 03/10/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 03/07/2025; 03/10/2025; 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CORAIL2 LAT COXA VARA SIZE 12.
• Patient Sex: Unknown