MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NECK TRL 36 STD; FEMORAL TRIALS

Catalog Number	257636000
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
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.Additional narrative: investigation summary the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the spring deformed.Device had signs of usage on its overall surface and no other anomaly was identified on its surface.The observed condition of the device was consistent with exposure to unintended forces, like usage of excessive force while trialing or by assembling the mating device in a misaligned position.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.As per s-rom® modular hip system surgical technique, page 5 and 17, the next precautions need to be followed during the trial stem insertion using the neck trial: "assemble the trial implant by snapping the chosen neck onto the appropriate size distal stem trial.Align the lateral laser marks in neutral initially and introduce the trial neck and trial stem construct into the femoral canal.The trial neck can be adjusted in 10-degree increments or "clicks" until desired version is obtained.Tighten the trial neck to the trial stem using the nut tightener.Tip: the opposite end of the nut tightener will thread onto the stem trial for extraction, should that be necessary" and "introduce prior to trial reduction".A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was unable to be performed due to the post-manufacturing damage and as mating component was not returned for evaluation.The overall complaint was confirmed as the observed condition of the srom neck trl 36 std 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 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.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
The product damage has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.No patient involvement.

• Brand Name: SROM NECK TRL 36 STD
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23757039
• Report Number: 1818910-2025-21493
• Device Sequence Number: 13294792
• Product Code: HWT
• UDI-Device Identifier: 10603295147053
• UDI-Public: (01)10603295147053(10)MT30507
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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

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: 257636000
• Device Lot Number: MT30507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2021
• 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