MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	7236-2-848
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
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.The following devices were also listed in this report: device name 28mm std lfit v40 head; cat# 6260-9-128; lot# 17893356.Device name modular dual mobility insert; cat# 626-00-42e; lot# 30051352.Device name uni adaptor sleeve v40 ti; cat# 6519-t-100; lot# 29609555.Device name 6.5mm low profile hex screw 20mm; cat# 7030-6520; lot# jrud.Device name delta un.Fem hd 28mm r28 16/18; cat# 6519-1-028; lot# 25561652.Device name 6.5mm low profile hex screw 35mm; cat#7030-6535; lot# kdgj.Device name tridentii tritanium multi 54e; cat#709-04-54e; lot# 29653651a.Device name 6.5mm low profile hex screw 20mm; cat# 7030-6520; lot# mu6e.Device name 6.5mm low profile hex screw 15mm; cat# 7030-6515; lot# mxy.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The following information was provided: right hip revision, patient presented with an infected surgical site.Surgeon swapped the liner, insert, and head, and all other components were left in-situ at this time.No complaints filed against the components themselves, and no further information available.

• Brand Name: RESTORATION ADM X3 INS 28/48
• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 23529256
• Report Number: 0002249697-2025-01315
• Device Sequence Number: 10202005
• Product Code: JDI
• UDI-Device Identifier: 07613327315974
• UDI-Public: 07613327315974
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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: 7236-2-848
• Device Lot Number: WK6W3J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• 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 Age: 63 YR
• Patient Sex: Male