MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS ACE IMP CURVED; HIP INSTRUMENT - IMPACTOR

Catalog Number	481201550
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cup handle was stuck on cup during cup implantation.There was no patient harm or surgical delay.
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 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.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 cup handle is stuck on cup during cup implantation.There was no patient harm or surgical delay.Please ship replacement to atrium health lake norman attn fletcher fortune.The product was returned to depuy synthes for evaluation.Visual analysis found that the emsys ace imp curved was returned engaged with an emsys shl 3hole 48.The threaded tip surface could not be examined due to the observed condition.Additionally the sample exhibits signs of multiple use for a long period of time.The observed condition of the device could be consistent with exposure to unintended forces, such as overtightening during assembly, which may have led to internal damage.However, since the devices were unable to be disengaged and the threaded section was not clearly visible, it was difficult to determine the exact cause of the reported condition.Therefore, a definitive root cause cannot be established.As per emphasys¿ acetabular solutions.Surgical technique, the following steps need to be followed: 1)"after confirming alignment, remove the inclination guide and adaptor from the strike plate"; 2) "impact the prosthesis into position until fully seated"; 3) "press the release on the side of the impactor to disengage the locking mechanism"; 4) "slot the ball hex driver into the housing and rotate the hex driver counterclockwise to unthread the prosthesis".Additionally, "if the shell is torqued onto the handle, unthreading may become difficult.To overcome the torque, rotate the entire curved handle, which will break the tension between the handle and the shell.Continue unthreading with the hex driver as usual".Functional test revealed the tip of the emsys ace imp curved and the threaded surface of the cup jammed together, and unable to be disassembled from one another.Confirming the reported allegation.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the emsys ace imp curved would have 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: h3.

• Brand Name: EMSYS ACE IMP CURVED
• Common Device Name: HIP INSTRUMENT - IMPACTOR
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24199167
• Report Number: 1818910-2026-01703
• Device Sequence Number: 5430950
• Product Code: HWA
• UDI-Device Identifier: 10603295504061
• UDI-Public: (01)10603295504061(10)PC5805080
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 01/28/2026

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: 481201550
• Device Lot Number: PC5805080
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 02/09/2026; 03/05/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/11/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 48 YR
• Patient Sex: Female