MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 PS TIBIAL INSERT #7 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	82-7-0708
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had complained about knee pain 13 years after bilateral tkr was done.Doctor is still assessing the root cause of pain and yet to decide on revision.Left knee.
Additional Manufacturer Narrative
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
It was reported that patient had complained about knee pain 13 years after bilateral tkr was done.Doctor is still assessing the root cause of pain and yet to decide on revision.Left knee.
Additional Manufacturer Narrative
The following devices were also listed in this report: scorpio nrg ps femoral #8 left; cat# 81-4408l; lot# mht1eh.Series 7000 standard tibia; cat# 7115-0007 ; lot# mjda2a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding pain involving a scorpio insert 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 remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: "these product inquiries concern a 70-year-old female who underwent a bilateral total knee arthroplasty with scorpio nrg prostheses.Approximately 13 years after the procedures were done the patient began to complain of knee pain.The cause of the knee pain has yet to be determined and the revision date for the right knee was to be determined and no revision was contemplated as yet on the left.No other information was provided.The root cause of bilateral knee pain 13 years after the index procedure cannot be determined with certainty with the information provided.The causes of pain following bilateral total knee arthroplasty many years afterwards are multifactorial including initial surgical technique, patient activity level and bmi, as well as bone quality.Loosening, osteolysis and instability are possible, as well as infection.There is no information that would attribute any causality to the implants themselves.It would be helpful to see a full x-ray series since it is possible that the patellofemoral articulation could be the source of pain since it has not been resurfaced." -product history review: review of the device history records indicate the 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 is experiencing pain 13 years post-operative.A review of the provided medical records by a clinical consultant indicated: "the root cause of bilateral knee pain 13 years after the index procedure cannot be determined with certainty with the information provided.The causes of pain following bilateral total knee arthroplasty many years afterwards are multifactorial including initial surgical technique, patient activity level and bmi, as well as bone quality.Loosening, osteolysis and instability are possible, as well as infection.There is no information that would attribute any causality to the implants themselves.It would be helpful to see a full x-ray series since it is possible that the patellofemoral articulation could be the source of pain since it has not been resurfaced." 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: SCORPIO NRG X3 PS TIBIAL INSERT #7 8MM
• 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-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 17330149
• Report Number: 0002249697-2023-00778
• Device Sequence Number: 5536950
• Product Code: JWH
• UDI-Device Identifier: 07613327031003
• UDI-Public: 07613327031003
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 06/30/2014
• Device Model Number: 82-7-0708
• Device Catalogue Number: 82-7-0708
• Device Lot Number: 30504501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2009
• 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: Other
• Patient Sex: Female