MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DUR MAR 10D LINER 28IDX58OD; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number	122028158
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
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 the patient experienced polyethylene wear of the right-side inlay following hip surgery.Patient outcome is reported as fully recovered.
Additional Manufacturer Narrative
Product complaint # = >(b)(4).Investigation summary = > no device associated with this report was received for examination.According to the information received,¿ right inlay, pe worn out".Quantity manufactured: (b)(4).Date of manufacture: 04/05/2023 any anomalies or deviations identified in dhr: none expiry date: 03/31/2028 ifu reference: (b)(4) ¿ instruction 902-22-701.A manufacturing record evaluation was performed for the finished device product description: dur mar 10d liner 28idx58od, product code: 122028158, lot number: 4137749 and no non-conformance was identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot = > quantity manufactured: (b)(4).Date of manufacture: 04/05/2023 any anomalies or deviations identified in dhr: none expiry date: 03/31/2028 ifu reference: (b)(4) ¿ instruction 902-22-701.Device history review = > a manufacturing record evaluation was performed for the finished device product description: dur mar 10d liner 28idx58od, product code: 122028158, lot number: 4137749 and no non-conformance was identified.

• Brand Name: DUR MAR 10D LINER 28IDX58OD
• Common Device Name: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24547452
• Report Number: 1818910-2026-04436
• Device Sequence Number: 5662135
• Product Code: LPH
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K994415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 122028158
• Device Lot Number: 4137749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown