MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah MODULAR DUAL MOBILITY INSERT; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous

Catalog Number	626-00-38D
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury

• Brand Name: MODULAR DUAL MOBILITY INSERT
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50572603
• Report Number: 0002249697-2026-00804
• Device Sequence Number: 21318941
• Product Code: LZO
• UDI-Device Identifier: 04546540666000
• UDI-Public: 04546540666000
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K250989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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 Catalogue Number: 626-00-38D
• Device Lot Number: 22248351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female