MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG CR FEMORAL COMPONENT RIGHT #5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	80-4405R
Medical Device Problem Codes	Unstable (1667); Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Arthritis (1723); Insufficient Information (4580)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Aseptic mobilization of the prosthesis.Reason the device was used: right knee osteoarthritis.Total right knee replacement.Year of implant: 2017.
Additional Manufacturer Narrative
An event regarding instability and loosening involving a scorpio femoral component was reported.Instability was confirmed via review of the provided medical records by a clinical consultant.Loosening was not confirmed.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the device indicated that the device has cement adhered to the bone-interfacing side of the device.There is nothing remarkable to note.-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.Conclusions: it was reported that the patient was revised due to aseptic loosening.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the device indicated that the device has cement adhered to the bone-interfacing side of the device.There is nothing remarkable to note.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." 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
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 CR FEMORAL COMPONENT RIGHT #5
• Common Device Name: 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14634103
• Report Number: 0002249697-2022-00810
• Device Sequence Number: 20306794
• Product Code: JWH
• UDI-Device Identifier: 07613327030303
• UDI-Public: 07613327030303
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K042343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2022

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: 04/30/2021
• Device Model Number: 80-4405R
• Device Catalogue Number: 80-4405R
• Device Lot Number: DY2A72
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2016
• 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 Sex: Unknown