MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah RESTORATION ADM X3 INS 28/52; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Catalog Number	7236-2-852
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left hip was revised.After a history of multiple dislocations, a competitor hip was revised with stryker acetabular components and competitor head and sleeve.Patient dislocated again, and surgeon noted a pelvic fracture (also noting patient has poor bone quality).All implants were removed and a girdlestone procedure was performed.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
The following devices were also listed in this report: 6.5mm low profile hex screw 40mm; cat# 7030-6540; lot# unknown.6.5mm low profile hex screw 25mm; cat# 7030-6525 ; lot# unknown.6.5mm low profile hex screw 25mm; cat# 7030-6525; lot# unknown.6.5mm low profile hex screw 20mm; cat# 7030-6520; lot# unknown.Modular dual mobility ins; cat# 626-00-46f; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: RESTORATION ADM X3 INS 28/52
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
• Manufacturer (Section D): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50102143
• Report Number: 0002249697-2026-00661
• Device Sequence Number: 5253992
• Product Code: JDI
• UDI-Device Identifier: 07613327315967
• UDI-Public: 07613327315967
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K250989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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: 7236-2-852
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Disability; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female