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

Catalog Number	7236-2-848
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: modular dual mobility insert; cat# 626-00-42e; lot# 94738301, tridentii tritanium solid 52e; cat# 700-04-52e; lot# 95720701a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Pt was experiencing hip pain.Pt had hip revision to replace mdm liner with a poly liner.Right th rev.
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a adm liner was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.Clinician review: i can confirm that the patient underwent a primary right cementless total hip arthroplasty since i was able to review an x-ray with the implant in place.I cannot confirm that the patient underwent revision surgery since i have no documentation.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of revision requiring removal of an mdm implant and replacing with a polyethylene implant are multifactorial.Causes include surgical technique regarding initial position and fixation of the implants and whether or not impingement occurs.It is unclear as to what the diagnosis was and the reason for conversion from an mdm to a polyethylene liner.Patient factors including activity level, lifestyle and bmi can also contribute.With the information provided i cannot assign any causality to the implant itself.N.B.Any and all explanted parts or prostheses should be submitted to stryker engineers for complete metallurgical and/or microscopic evaluation and analysis." product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to pain.I can confirm that the patient underwent a primary right cementless total hip arthroplasty since i was able to review an x-ray with the implant in place.I cannot confirm that the patient underwent revision surgery since i have no documentation.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of revision requiring removal of an mdm implant and replacing with a polyethylene implant are multifactorial.Causes include surgical technique regarding initial position and fixation of the implants and whether or not impingement occurs.It is unclear as to what the diagnosis was and the reason for conversion from an mdm to a polyethylene liner.Patient factors including activity level, lifestyle and bmi can also contribute.With the information provided i cannot assign any causality to the implant itself.N.B.Any and all explanted parts or prostheses should be submitted to stryker engineers for complete metallurgical and/or microscopic evaluation and analysis." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.Correction: g1.
Event or Problem Description
No new information.

• Brand Name: RESTORATION ADM X3 INS 28/48
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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 ; 2018315000
• MDR Report Key: 23708779
• Report Number: 0002249697-2025-01403
• Device Sequence Number: 10673511
• Product Code: MEH
• UDI-Device Identifier: 07613327315974
• UDI-Public: 07613327315974
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 7236-2-848
• Device Lot Number: 91198001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 82 KG