MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ACTIS COLLARED HIGH SIZE 8; HIP FEMORAL STEM

Catalog Number	101012080
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
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.Additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that patient underwent a left total hip on (b)(6) 2025.During the procedure, the 8 high offset stem was open and one of the inner packages was never sealed or sterilized.It could be seen on the package that one side was never "pressed closed;" it was just left wide open.The stem did not enter the sterile field.Affected side: unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿it was reported that the 8 high offset stem was open and one of the inner packages was never sealed or sterilized.They can see on the package that one side was never "pressed closed", it was just left wide open.It will be having office send back the stem and packaging asap¿.The actis collared high size 8 (lot.4800140) returned to depuy synthes for evaluation.The complaint unit was forwarded to the manufacturing site for further evaluation.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.However, even if the integrity of the secondary barrier seal was compromised, 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 compromised, the risk should be considered low.The manufacturing investigation confirmed that the reported condition was attributable to a manufacturing issue related to human error due to breakdown in visual inspection of the outer pouch.The overall complaint was confirmed as the observed condition of the actis collared high size 8 would contribute 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 depuy synthes 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 [101012080 /4800140] and no non-conformances or manufacturing irregularities were identified.However an nc was raised to address the reported issue.Device history batch: null.Device history review : a manufacturing record evaluation was performed for the finished device [101012080 /4800140] and no non-conformances or manufacturing irregularities were identified.However an nc was raised to address the reported issue.Added: d4 (expiry date), h4.Corrected: d4 (primary udi), h3.

• Brand Name: ACTIS COLLARED HIGH SIZE 8
• Common Device Name: 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 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22439269
• Report Number: 1818910-2025-11589
• Device Sequence Number: 14610526
• Product Code: MEH
• UDI-Device Identifier: 10603295380603
• UDI-Public: (01)10603295380603(17)340430(10)4800140
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202472
• 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

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: 101012080
• Device Lot Number: 4800140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• 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