MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 22 +0 FEMORAL HEAD TRIALS, REP; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number	875917
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2026
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 report, a follow-up report will be filed as appropriate.Additional narrative: h3, h6: 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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis revealed that a portion of the bottom surface was broken; fragments were not returned for evaluation.Additionally, deep scratches were observed all over the outer surface, consistent with other tools and hard edges coming in contact with the device.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces, such as, heavy usage during the disassembly process and off axis impaction forces.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection and functional testing were not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the 22 +0 femoral head trials, rep would contribute 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.
Event or Problem Description
It was reported that the impacted products had an unknown allegation.Happened in surgery.Doe: (b)(6) 2026.Affected side: unknown.

• Brand Name: 22 +0 FEMORAL HEAD TRIALS, REP
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24681088
• Report Number: 1818910-2026-05188
• Device Sequence Number: 18573593
• Product Code: HWT
• UDI-Device Identifier: 10603295218746
• UDI-Public: (01)10603295218746(10)AZ492439
• Combination Product (Y/N): N
• 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

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: 875917
• Device Lot Number: AZ492439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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