MAUDE Adverse Event Report: DEPUY IRELAND ACTIS COLLARED STD SIZE 8; HIP FEMORAL STEM

Catalog Number	101011080
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
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.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 during a total hip replacement surgical procedure, the head ball was scratched due to the impactor tip breaking and so the surgeon wanted a new one.When the surgeon attempted to knock the head off the stem to replace, surgeon could not get the head to disassociate from the stem and the entire prosthesis came out.The surgeon had to insert a new stem because the surgeon was unable to separate the two implants.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9, d10 concomitant.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: it was reported that the head ball was scratched due to the impactor tip breaking and so the surgeon wanted a new one.When the surgeon attempted to knock the head off the stem to replace, surgeon could not get the head to disassociate from the stem and the entire prosthesis came out.Surgeon had to insert a new stem because surgeon was unable to separate the two implants.The product was returned to depuy synthes for evaluation.Visual analysis found that the actis collared std size 8 was returned assembled properly with the delta cer head 12/14 36mm +1.5.No damage potentially related to the reported event was observed.The assessment was performed manually and the implants functioned satisfactorily.A dimensional inspection was not performed since it was not applicable to the complaint condition.A search of the depuy synthes nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.The overall complaint was not confirmed as the observed condition of the actis collared std size 8 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 reported complaint condition.As part of depuy synthes 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 search of the depuy synthes nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: ACTIS COLLARED STD SIZE 8
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND; 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: 23759928
• Report Number: 1818910-2025-21519
• Device Sequence Number: 15981863
• Product Code: MEH
• UDI-Device Identifier: 10603295380481
• UDI-Public: (01)10603295380481(17)UNKNOWN(10)D25093743
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 12/09/2025

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: 101011080
• Device Lot Number: D25093743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 01/16/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/13/2026; 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DELTA CER HEAD 12/14 36MM +1.5.
• Patient Age: 68 YR
• Patient Sex: Female