MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	7236-2-854
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/27/2024
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.
Event or Problem Description
It was reported by sale rep that the revision surgery revision surgery will be performed on (b)(6) 2024 due to patient x-ray shows dislocated after the primary surgery.
Event or Problem Description
It was reported by sale rep that the revision surgery revision surgery will be performed on (b)(6) 2024 due to patient x-ray shows dislocated after the primary surgery.Update: the adm x3 dislocated from the mdm metal liner.The surgical treatment for the disease is stem replacement.The revision surgery was performed and reinserted into the patient except the stem as the original stem size was unable to be used.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a mdm liner was reported.The event was confirmed via medical review.Method & results: device 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: conclusion/assessment: no medical records, surgical records or revision records were provided for review.Photos of x-rays show a dislocated mdm-accolade tha construct.Of note, full seating of the mdm liner cannot be determined.Event confirmation: a dislocation can be confirmed.A revision cannot be confirmed but would be expected.It cannot be determined if this was a ¿dislocation¿ vs an intra-prosthetic dislocation.Root cause: the root cause of the dislocation cannot be determined without additional medical information.The root cause of the revision, if confirmed, would be a dislocated mdm construct.Device history review: a review of the device history records indicates devices were manufactured and accepted into final stock with no relevant reported 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 dislocation.A review of the provided medical records by a clinical consultant indicated: conclusion/assessment: no medical records, surgical records or revision records were provided for review.Photos of x-rays show a dislocated mdm-accolade tha construct.Of note, full seating of the mdm liner cannot be determined.Event confirmation: a dislocation can be confirmed.A revision cannot be confirmed but would be expected.It cannot be determined if this was a ¿dislocation¿ vs an intra-prosthetic dislocation.Root cause: the root cause of the dislocation cannot be determined without additional medical information.The root cause of the revision, if confirmed, would be a dislocated mdm construct.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 28/54
• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20510037
• Report Number: 0002249697-2024-01447
• Device Sequence Number: 9088027
• Product Code: JDI
• UDI-Device Identifier: 07613327315820
• UDI-Public: 07613327315820
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: 7236-2-854
• Device Lot Number: LOT 19076951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 01/25/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2024
• 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: 73 YR
• Patient Sex: Male