MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 10; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92500
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	11/07/2024
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: the expiration date is currently not available.Therefore, the full udi is currently not available.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 the package of the device is damaged.The plastic packaging cracked.There was no patient involvement.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: damaged package on 1 piece [product code and lot removed].The product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed that the outer packaging of the universal fem slv ful por 46mm was damaged, the shrink-wrap plastic was torn and partially open from the right side.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.A manufacturing record evaluation was performed for the finished device product description: corail amt collar size 10 product code: 3l92500 lot number: 5758328 and no non-conformances or manufacturing irregularities were identified.The overall complaint was confirmed as the observed condition of the corail amt collar size 10 contributed to the complained device issue.Ased 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 manufacturing record evaluation was performed for the finished device product description: corail amt collar size 10 product code: 3l92500 lot number: 5758328 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 10 product code: 3l92500 lot number: 5758328 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.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: damaged package on 1 piece [product code and lot removed].The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the outer packaging of the corail amt collar size 10 was damaged, the shrink-wrap plastic was torn and partially open from the right side.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 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 collar size 10 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 manufacturing record evaluation was performed for the finished device product description: corail amt collar size 10 product code: 3l92500 lot number: 5758328 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 10 product code: 3l92500 lot number: 5758328 and no non-conformances or manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: damaged package on 1 piece [product code and lot removed].The product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed that the outer packaging of the universal fem slv ful por 46mm was damaged, the shrink-wrap plastic was torn and partially open from the right side.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.A manufacturing record evaluation was performed for the finished device product description: corail amt collar size 10 product code: 3l92500 lot number: 5758328 and no non-conformances or manufacturing irregularities were identified.The overall complaint was confirmed as the observed condition of the corail amt collar size 10 contributed to the complained device issue.Ased 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 manufacturing record evaluation was performed for the finished device product description: corail amt collar size 10 product code: 3l92500 lot number: 5758328 and no non-conformances or manufacturing irregularities were identified.A manufacturing record evaluation was performed for the finished device product description: corail amt collar size 10 product code: 3l92500 lot number: 5758328 and no non-conformances or manufacturing irregularities were identified.
Event or Problem Description
Additional information received states that there was no patient involvement.

• Brand Name: CORAIL AMT COLLAR SIZE 10
• 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 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20709198
• Report Number: 1818910-2024-24011
• Device Sequence Number: 15506734
• Product Code: LZO
• UDI-Device Identifier: 10603295168669
• UDI-Public: (01)10603295168669(17)290831(10)5758328
• 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,Distributor
• 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: 3L92500
• Device Lot Number: 5758328
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 12/04/2024; 12/26/2024; 12/30/2024; 12/31/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/05/2024; 12/27/2024; 12/30/2024; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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: CORAIL AMT COLLAR SIZE 10
• Patient Sex: Unknown