MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ACTIS COLLARLESS HIGH SZ 5; HIP IMPLANT - HIP FEMORAL STEM

Catalog Number	101022050
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Limb Fracture (4518)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent a tha surgery treating the left hip joint.The surgery was completed successfully with no surgical delay.After the surgery, during rehabilitation (while hospitalized), the patient suffered a fracture in the proximal femur and stem subsidence.A revision surgery is scheduled for (b)(6) 2025.In the revision surgery, the stem will be replaced with a competitor's cone.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: according to the information received, "it was reported that on (b)(6) 2025, the patient underwent a tha surgery treating the left hip joint.The surgery was completed successfully with no surgical delay.After the surgery, during rehabilitation (while hospitalized), the patient suffered a fracture in the proximal femur and stem subsidence.A revision surgery is scheduled for on (b)(6) 2025.In the revision surgery, the stem will be replaced with a zimmer biomet¿s wagner cone.The surgeon commented and requested as follows: i have never experienced anything like this event with the previous products including trilock products i used.This event seems to be related to the characteristics of the stem, which is worrying.I would like to know if a similar event has occurred.No further information is available".The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.After radiological evaluation and since no chronological evidence was provided for review, there is no clear evidence of movement nor other defect that could have contributed nor verified the reported allegation.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 m20z10 number, and no non-conformance's nor manufacturing irregularities were identified.The overall complaint was not confirmed as the observed condition of the actis collarless high sz 5 would have not contributed to the complained device 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 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 m20z10 number, and no non-conformance's nor manufacturing irregularities were identified.

• Brand Name: ACTIS COLLARLESS HIGH SZ 5
• Common Device Name: HIP IMPLANT - HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• 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: 21752952
• Report Number: 1818910-2025-04956
• Device Sequence Number: 15993099
• Product Code: MEH
• UDI-Device Identifier: 10603295526773
• UDI-Public: (01)10603295526773(17)330731(10)M20Z10
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101022050
• Device Lot Number: M20Z10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown