MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL AMT COLLAR SIZE 8; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92498
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Reported patient underwent arthroplasty.The size 8 collared corail outer peel pack wasn¿t sealed on one side and fell on the ground as it was handed to nurse to open and as she broke the angled seal side it slid out the bottom of the unseal portion and fell onto the floor.Decided at that point to just grab another stem to open.Procedure was successfully completed with no delay.No patient consequence.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary the size 8 collared corail (3l92498) outer peel pack wasn¿t sealed on one side and fell on the ground as it was handed to nurse to open and as she broke the angled seal side it slid out the bottom of the unseal portion and fell onto the floor.Decided at that point to just grab another stem to open.The product was not returned to j&j medtech orthopaedics; however photos were provided for review.See attachment img_3958.Jpeg,img_3973.Jpeg.Additionally, a manufacturing investigation was raised for the complaint issue.The photo investigation found that the outer pouch (secondary sterile barrier) wasn¿t vacuum sealed; the pouch does not have any evidence of heat-sealed application to it.Based on the manufacturing investigation, it was confirmed that the reported condition was caused by a manufacturing issue; the assignable cause was related to human error.The secondary sterile barrier exists to minimize risk of introducing microbial contamination to the surgical suite during the presentation of the device (within its primary packaging).Even if the integrity of the secondary barrier seal was compromized, it would be expected that the inner packaging would not be appreciably contaminated as microbial bioburden on packaging is primarily introduced through direct contact (handling).As such, whilst there is additional risk of introducing contamination to the surgical suite as a result of the secondary sterile barrier being compromized, the risk should be considered low.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 8 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 a manufacturing record evaluation was performed for the finished device [3l92498/4639251] and no non-conformances or manufacturing irregularities were identified.However an nc was raised to address the reported issue.Device history review a manufacturing record evaluation was performed for the finished device [3l92498/4639251] and no non-conformances or manufacturing irregularities were identified.However an nc was raised to address the reported issue.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary.The size 8 collared corail (3l92498) outer peel pack wasn¿t sealed on one side and fell on the ground as it was handed to nurse to open and as she broke the angled seal side it slid out the bottom of the unseal portion and fell onto the floor.Decided at that point to just grab another stem to open.The product was returned to j&j medtech orthopaedics for evaluation.Additionally a manufacturing investigation was raised for the complaint issue.Visual inspection of the returned device found that the outer pouch (secondary sterile barrier) wasn¿t vacuum sealed; the pouch does not have any evidence of heat sealed application to it.Based on the manufacturing investigation, it was confirmed that the reported condition was caused by a manufacturing issue; the assignable cause was related to human error.The secondary sterile barrier exists to minimize risk of introducing microbial contamination to the surgical suite during the presentation of the device (within its primary packaging).Even if the integrity of the secondary barrier seal was compromized, it would be expected that the inner packaging would not be appreciably contaminated as microbial bioburden on packaging is primarily introduced through direct contact (handling).As such, whilst there is additional risk of introducing contamination to the surgical suite as a result of the secondary sterile barrier being compromized, the risk should be considered low.The overall complaint was confirmed as the observed condition of the corail amt collar size 8 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.A manufacturing record evaluation was performed for the finished device [3l92498/4639251] and no non-conformances or manufacturing irregularities were identified.However, an nc was raised to address the reported issue.Device history review.A manufacturing record evaluation was performed for the finished device [3l92498/4639251] and no non-conformances or manufacturing irregularities were identified.However, an nc was raised to address the reported issue.H11 additional narrative: added: d9.Corrected: h3.

• Brand Name: CORAIL AMT COLLAR SIZE 8
• 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 ; 9083863534
• MDR Report Key: 22781918
• Report Number: 1818910-2025-14011
• Device Sequence Number: 10046013
• Product Code: LZO
• UDI-Device Identifier: 10603295168645
• UDI-Public: (01)10603295168645(17)20350131(10)4639251
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 3L92498
• Device Lot Number: 4639251
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 09/29/2025; 09/29/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/29/2025; 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• 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 Age: 65 YR
• Patient Sex: Female