MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah MODULAR DUAL MOBILITY INS; 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	08/26/2026
Type of Reportable Event	Serious Injury

• Brand Name: MODULAR DUAL MOBILITY INS
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50845439
• Report Number: 0002249697-2026-00870
• Device Sequence Number: 10270331
• Product Code: LZO
• UDI-Device Identifier: 04546540666000
• UDI-Public: 04546540666000
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K250989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 23370952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2024
• 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: 79 YR
• Patient Sex: Female