MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 CR TIBIAL INSERT #5 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 82-6-0510

Device Problems Degraded (1153); Unstable (1667)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2022

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding instability and wear involving a scorpio insert was reported.The events were confirmed via evaluation of the provided photographs of the device and through review of the provided medical records by a clinical consultant.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient underwent a cemented scorpio total knee arthroplasty in 2017.According to the summary the implant was removed on (b)(6) 2022 for "aseptic loosening of the prosthesis." i cannot confirm that revision occurred since i have no supporting evidence to document this such as office notes, an operation note or post revision x-rays.I also cannot confirm that aseptic loosening of the prosthesis occurred.The x-rays provided, in my opinion show that the patient has gross instability of the implant.I see no evidence of loosening of either the femoral or tibial component but, granted, only two x-rays are provided.The causes of late instability of a cemented total knee arthroplasty are multifactorial including surgical technique, patient factors including bmi and activity level.It would be unusual to implicate implant factors as a cause of instability." product history review: review of the device history records indicate 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.

Event Description

Aseptic loosening of the prosthesis.Reason the device was used: right knee osteoarthritis.Total right knee replacement.Year of implant: 2017.Update per med review: "there is rather profound anterior subluxation of the tibia on femur indicating gross instability.".

• Brand Name: SCORPIO NRG X3 CR TIBIAL INSERT #5 10MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15649714
• MDR Text Key: 302171740
• Report Number: 0002249697-2022-01535
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07613327030501
• UDI-Public: 07613327030501
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K071991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 82-6-0510
• Device Catalogue Number: 82-6-0510
• Device Lot Number: 3P86Y1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85