MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah DELTA C-TAPER HEAD 36MM +2.5; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous

Catalog Number	18-3625
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: on (b)(6) 2026, a sales representative received an email from reporting that a patient had presented for medical consultation complaining of pain in the right hip, which had undergone a right total hip arthroplasty (tha) with a trident-accolade prosthesis at another clinic in 2019.X-rays showed a loss of symmetry and misalignment of the hip head relative to the neck.A computed tomography (ct) scan confirmed that the stem was broken at the neck.On (b)(6) 2026, surgical revision was performed, revealing a loose ceramic head, a stem with an axially broken neck, and a missing fragment, all associated with significant metallosis and severe osteolysis of the proximal femur where the stem was located.The surgeon was able to clean the area, remove all debris, and reconstruct the hip with a reconstruction stem and replace the lining.In the attachment-intake are pictures of the surgery revision.
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: DELTA C-TAPER HEAD 36MM +2.5
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous
• Manufacturer (Section D): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): Stryker Orthopaedics-Cork; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25072462
• Report Number: 0002249697-2026-00366
• Device Sequence Number: 10747839
• Product Code: LZO
• UDI-Device Identifier: 07613154187331
• UDI-Public: 07613154187331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2022
• Device Catalogue Number: 18-3625
• Device Lot Number: 61266103
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2017
• 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; Hospitalization
• Patient Sex: Female