MAUDE Adverse Event Report: DEPUY IRELAND EMSYS TRL SHL M 53; HIP INSTRUMENT - ACETABULAR TRIAL

Catalog Number	481053900
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that the cup trial would not come off the cup inserter handle.There was no patient or procedure involvement; this occurred after the case as one tech was showing another how to use the instrumentation.
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 that 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 that was not available for the initial report is obtained, 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 that 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: d4 lot, h4.Corrected: d4 primary udi number.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary according to the information provided: "it was reported that the cup trial wil not come off cup inserter handle, scrub tech assembled after the case to show another tech how they went together, no impact to patient, no surgery delay, all pieces accounted for".The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed of the returned device revealed signs of usage on its overall surface.Additionally, the emsys trl shl m 53 was found assembled with its mating component (emsys ace imp straight).No other anomaly was identified.A dimensional inspection was not performed since it was not applicable to the complaint condition.Functional test revealed the tip of the emsys ace imp straight and the threaded surface of the emsys trl shl m 53 jammed together, and unable to be disassembled from one another.Threaded surface was unable to be inspected as a consequence of the observed damage.With information provided, and without further evidence, a specific root cause could not be established for this issue.However, consideration must be given to all other potential causes, including the possibility of a component failure caused by exposure to unintended forces; overtightening the device while assemblance; assembling the device in a misaligned position; or by impacting the device before it was fully seated.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.As per emphasys¿ acetabular solutions surgical technique, 103736384 rev h and page 6 and 12, the following precautions need to be followed: 1)"align the threaded hole in the trial shell with the threaded tip of the impactor"; 2) "securely thread the trial shell onto the impactor"; 3) "tighten the thread sufficiently to prevent unintentional loosening during impaction"; 4) "after confirming alignment, impact the prosthesis into position until fully seated"; 5) full seating may require additional impaction; 6) "if adjustments to the shell orientation are necessary, re-attach the instrument into the apical hole to adjust the shell position".The overall complaint was confirmed as the observed condition of the emsys trl shl m 53 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 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.H11 additional narrative: corrected: h3.

• Brand Name: EMSYS TRL SHL M 53
• Common Device Name: HIP INSTRUMENT - ACETABULAR TRIAL
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22992637
• Report Number: 1818910-2025-15384
• Device Sequence Number: 15819941
• Product Code: HWT
• UDI-Device Identifier: 10603295503996
• UDI-Public: (01)10603295503996(10)GM6178003
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,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: 481053900
• Device Lot Number: GM6178003
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 09/10/2025; 09/11/2025; 10/17/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 09/11/2025; 09/12/2025; 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2023
• 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 Age: 67 YR
• Patient Sex: Female