MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS TRL LNR N 52X36; HIP INSTRUMENT - ACETABULAR TRIAL LINER

Catalog Number	482252036
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that emphasys trial liners have chips and cracks.The issue was found during use.There was no reported patient or user harm, but a surgical delay occurred during the procedure.
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary = > according to the information received, it was reported that the chips and cracks in 2 emphasis trial liners.The product was not returned to depuy synthes; however, photos were provided for review.See attachment ([(b)(4).Device photo ad (b)(6) 2026]).The photo investigation revealed that the emsys trl lnr n 52x36 is chipped at the rim, no crack could be observed.Additionally, scratches were found on the convex section.The condition found can be attributed to a combination of heavy use and exposure to unintended forces during repeated attempts at assembly and disassembly with the mating device and other tools and hard edges coming in contact with the device.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the emsys trl lnr n 52x36 would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error, and 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 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 LNR N 52X36
• Common Device Name: HIP INSTRUMENT - ACETABULAR TRIAL LINER
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24490182
• Report Number: 1818910-2026-03931
• Device Sequence Number: 16123683
• Product Code: HWT
• UDI-Device Identifier: 10603295510413
• UDI-Public: (01)10603295510413(10)891531
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 482252036
• Device Lot Number: 891531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• 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