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

Model Number	82-7-0510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/08/2021
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
It was reported by sale rep that surgeon informed patient need to go for change of insert due to infection.
Additional Manufacturer Narrative
The following devices were also listed in this report: scorpio nrg ps femoral #6 left; cat#: 81-4406l; lot#: ty01km.Series 7000 standard tibia; cat#: 7115-0005; lot#: t81w5e.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 infection involving a scorpio insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: event: event date: on (b)(6) 2021.Event description: it was reported by sales rep that surgeon informed patient need to go for change of insert due to infection.Implants involved: scorpio nrg x3 ps size #5 10mm.Anatomic site: knee.Materials reviewed: 04/08/2021: stryker report.Undated/unlabeled: x-ray knee ap.Scorpio style cemented tka.No obvious abn.Confirmation: the event cannot be confirmed without additional medical records.Root cause: the root cause cannot be determined as the event could not be confirmed.Device history review: review indicated the devices accepted into final stock from the reported lot were free from discrepancies.   complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusion: the event could not be confirmed as insufficient information was provided.Further information such as pathology repots, return of the device, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.  additional information including pathology reports, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported by sale rep that surgeon informed patient need to go for change of insert due to infection.

• Brand Name: SCORPIO NRG X3 PS TIBIAL INSERT #5 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11770067
• Report Number: 0002249697-2021-00780
• Device Sequence Number: 14495191
• Product Code: JWH
• UDI-Device Identifier: 07613327030938
• UDI-Public: 07613327030938
• 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: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: 10/31/2022
• Device Model Number: 82-7-0510
• Device Catalogue Number: 82-7-0510
• Device Lot Number: 3826ED
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention