MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NRG KNEE P/S NRG BEARING INSERT SIZE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	82-3-0310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sale rep that patient needs a revision surgery due to infection.
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat# 81-4405l; scorpio nrg ps femoral no 5 left; lot# unknown.Cat# 7115-0004; series 7000 standard tibia; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported by the sale rep that patient needs a revision surgery due to infection.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a scorpio insert was reported.The event was not confirmed.Method & results: -device evaluation and results: the reported device was not returned but photographs were provided for review.A review indicated recently explanted devices covered in blood and tissue.Nothing remarkable noted.-clinician review: a review of the provided medical records by a clinical consultant stated the following comments: conclusion/assessment: by report only, bilateral revisions were performed for infection.X-rays showed stable implants.Event confirmation: the event cannot be confirmed as no medical records were provided that document the infection or revision.Root cause: a root cause cannot be stated as the events cannot be confirmed.-device history review: a review of the device history records could not be performed as lot code information was unknown.-complaint history review: complaint history review could not be performed as lot code information was unknown.Conclusion: the reported device was not returned but photographs were provided for review.A review indicated recently explanted devices covered in blood and tissue.Nothing remarkable noted.The event cannot be confirmed as no medical records were provided that document the infection or revision.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.

• Brand Name: NRG KNEE P/S NRG BEARING INSERT SIZE
• 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 NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18500409
• Report Number: 0002249697-2024-00069
• Device Sequence Number: 8146536
• Product Code: JWH
• UDI-Device Identifier: 04546540364289
• UDI-Public: 04546540364289
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K030978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: 82-3-0310
• Device Lot Number: UNKNOWN
• 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: 12/21/2023
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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