MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ACTIS COLLARED STD SIZE 3; HIP FEMORAL STEM

Catalog Number	101011030
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon opening the plastic sealed and undamaged cardboard box, it was realized that the hard plastic shell housing was cracked and the stem contaminated.No visible signs of damage to the outer cardboard box to suggest mishandling during shipping/handling.Doe: (b)(6) 2025, affected side: left hip.
Additional Manufacturer Narrative
Product complaint # (b)(6).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).Investigation summary: according to the information received, "it was reported that upon opening the plastic sealed and undamaged cardboard box, it was realized that the hard plastic shell housing was cracked and the stem contaminated.No visible signs of damage to the outer cardboard box to suggest mishandling during shipping/handling.Doe: (b)(6) 2025.Affected side: left hip." no device associated with this report was received for examination.Product description: -actis collared std size 3.Product code: - 101011030.Lot no: - 4245425.Quantity of manufactured: - (b)(4).Date of manufacturing: - 01-sep-2023.Expiry date: - 31-aug-2033.Ifu reference: - (b)(4).A manufacturing record evaluation was performed for the finished device product description: actis collared std size 3, product code: 101011030, lot number: 4245425 and one non-conformance was identified, however not related to the reported failure mode of the complaint.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 01-sep-2023.3) any anomalies or deviations identified in dhr: one non-conformance was identified, however not related to the reported failure mode of the complaint.4) expiry date: 31-aug-2033.5) ifu reference: (b)(4).Device history review: a manufacturing record evaluation was performed for the finished device product description: actis collared std size 3, product code: 101011030, lot number: 4245425 and one non-conformance was identified, however not related to the reported failure mode of the complaint.

• Brand Name: ACTIS COLLARED STD SIZE 3
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23746151
• Report Number: 1818910-2025-21395
• Device Sequence Number: 5904879
• Product Code: MEH
• UDI-Device Identifier: 10603295380436
• UDI-Public: (01)10603295380436(10)4245425
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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: 101011030
• Device Lot Number: 4245425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female