MAUDE Adverse Event Report: DePuy Ireland - 9616671 ACTIS; Hip Femoral Stem

Catalog Number	101012060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Joint Laxity (4526)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that altrx +4 10d 36idx54od was involved in a post-implant event concerning instability after a fall.During revision surgery, the insert was found to be no longer in its original position.The insert and femoral head were removed, new components were implanted, and implant stability was confirmed.The altrx +4 10d 36idx54od implant was explanted and is available for return.Delta cer head 12/14 36mm +1.5, pinn sector w/gription 54mm, and actis collared high size 6 were also involved in the revision procedure and were explanted.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11.Additional manufacturer narrative: e1 initial reporter address line 1: (b)(6).

• Brand Name: ACTIS
• Common Device Name: Hip Femoral Stem
• Manufacturer (Section D): DePuy Ireland - 9616671; 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 ; +1(908)386-3534
• MDR Report Key: 50146613
• Report Number: 1818910-2026-13411
• Device Sequence Number: 9092431
• Product Code: MEH
• UDI-Device Identifier: 10603295380580
• UDI-Public: (01)10603295380580(17)280627(10)M31C05
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 101012060
• Device Lot Number: M31C05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: Not provided; 09/22/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 08/19/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2023
• 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