MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS TRL SHL M 60; HIP INSTRUMENT - ACETABULAR TRIAL

Catalog Number	481060900
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
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.
Event or Problem Description
It was reported that the emphasys trial shell cross threaded onto the impactor when inspecting after procedure.
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.H10 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 it was reported that the emphasys trila shell cross threaded onto impactor when inspecting after procedure.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection reveled that the emsys trl shl m 60 was returned assembled to a mto kin v1 emsys off cup imp.It was not possible to verify the threaded section condition.The device shows signs of repetitive use.A functional evaluation was performed by trying to dissemble the mating device with excessive forces, however devices were unable to be disassembled, confirming the reported condition.It is suspected that the threads of the emsys trl shl m 60 were stripped.This type of damage suggest that the emsys trl shl m 60 threads became stripped due to its exposure to unintended and excessive forces such as, but not limited to, overtightening the threaded tip and impaction forces.However since they could not be disassembled, this cannot be conclusively substantiated.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 trl shl m 60 would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported 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.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.

• Brand Name: EMSYS TRL SHL M 60
• Common Device Name: HIP INSTRUMENT - ACETABULAR TRIAL
• 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: 22700172
• Report Number: 1818910-2025-13581
• Device Sequence Number: 9037098
• Product Code: HWT
• UDI-Device Identifier: 10603295503873
• UDI-Public: (01)10603295503873(10)GM5992804
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 481060900
• Device Lot Number: GM5992804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2025
• Supplement Date Received by Manufacturer: 08/07/2025; 09/12/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/08/2025; 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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 Sex: Unknown