MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	1236-2-244
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient was getting dressed and her leg caught in her pants and she fell on sunday 15 june dislocating her hip.They tried to relocate in emergency.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Corrected data: device details, gtin.An event regarding disassociation involving an adm liner was reported.The event was confirmed view review of the provided medical records by a clinician.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: a review of the provided medical records by a clinical consultant indicated: this is a single radiograph of the pelvis showing the same two implants the left hip is now a dislocated superiorly.The acetabular cup appears cementless and the femoral component is cemented in slight varus.Confirmation of event: i can confirm that the patient had a primary exeter total hip arthroplasty on the left side since i was able to see an x-ray with the implant in place.I cannot confirm the revision since i have no documentation.Root cause analysis: the root cause this event cannot be determined with certainty.The causes of dislocation approximately seven years after surgery are multifactorial including surgical technique, soft tissue balancing, possible polyethylene wear, possible trauma and possible impingement.Patient factors including lifestyle, activity level and bmi can also be considered.The only contributing causality from the implant side would be possible wear of the polyethylene which then allowed for laxity of the joint.-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 'patient was getting dressed and her leg caught in her pants and she fell on sunday 15 june dislocating her hip.They tried to relocate in emergency.' a review of the provided medical records by a clinical consultant indicated: this is a single radiograph of the pelvis showing the same two implants the left hip is now a dislocated superiorly.The acetabular cup appears cementless and the femoral component is cemented in slight varus.I can confirm that the patient had a primary exeter total hip arthroplasty on the left side since i was able to see an x-ray with the implant in place.I cannot confirm the revision since i have no documentation.The root cause this event cannot be determined with certainty.The causes of dislocation approximately seven years after surgery are multifactorial including surgical technique, soft tissue balancing, possible polyethylene wear, possible trauma and possible impingement.Patient factors including lifestyle, activity level and bmi can also be considered.The only contributing causality from the implant side would be possible wear of the polyethylene which then allowed for laxity of the joint.The exact cause of the event could not be determined because insufficient information was provided.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.

• Brand Name: RESTORATION ADM X3 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22485381
• Report Number: 0002249697-2025-00694
• Device Sequence Number: 8498719
• Product Code: LZO
• UDI-Device Identifier: 04546540665898
• UDI-Public: 04546540665898
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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 Expiration Date: 06/29/2023
• Device Catalogue Number: 1236-2-244
• Device Lot Number: 401039
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2018
• 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: 87 YR
• Patient Sex: Female
• Patient Weight: 70 KG