MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	1236-2-858
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding dislocation involving an 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: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock on with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: as reported: "revision of left total hip done today.This patient presented with a periprosthetic fracture of his right hip which was a competitor total hip.Originally the left hip was not a problem.The right hip was revised on (b)(6) 2025 to address the fracture using competitor products.After that surgery it was discovered that the left hip had dislocated.The left hip was reduced and transferred from trauma service to joint replacement service.It was discovered that the 28mm head had disassociated from the mdm poly liner.It is thought that this disassociation occurs when the hip was reduced.The revision today was to address the instability of the left hip.Mdm implants were removed and a constrained liner was placed.It was also decided to go from a +4 neck length to a +8 to address limb length discrepancy.No further information available from surgeon or hospital." 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.
Event or Problem Description
As reported: "revision of left total hip done today.This patient presented with a periprosthetic fracture of his right hip which was competitor total hip.Originally the left hip was not a problem.The right hip was revised on (b)(6) 2025 to address the fracture using competitor products.After that surgery it was discovered that the left hip had dislocated.The left hip was reduced and transferred from trauma service to joint replacement service.It was discovered that the 28mm head had disassociated from the mdm poly liner.It is thought that this disassociation occurs when the hip was reduced.The revision today was to address the instability of the left hip.Mdm implants were removed and a constrained liner was placed.It was also decided to go from a +4 neck length to a +8 to address limb length discrepancy.No further information available from surgeon or hospital." rep confirmed that intra-operatively, the poly was found floating in the joint.

• Brand Name: RESTORATION ADM X3 INS 28/58
• 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: 22638123
• Report Number: 0002249697-2025-00737
• Device Sequence Number: 18532794
• Product Code: MEH
• UDI-Device Identifier: 04546540639028
• UDI-Public: 04546540639028
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K093644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

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: 03/31/2026
• Device Catalogue Number: 1236-2-858
• Device Lot Number: 84048801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2021
• 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: 80 YR
• Patient Sex: Male