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

Catalog Number	81-4405R
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock on with no relevant reported discrepancies.Based on the device identification the complaint databases were reviewed for similar reported events regarding instability.There have been no other similar events for the reported lot.Device not available.
Event or Problem Description
It was reported that the patient's right knee was revised due to instability.No possible cause or contributor for instability was reported to the rep.The femoral component, insert, and cemented tibia were revised.None of the records accessible to rep confirmed the manufacturer of the cement.Rep reported that x-rays, medical records, and additional information are not available.

• Brand Name: SCORPIO NRG PS FEMORAL #5 RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8170207
• Report Number: 0002249697-2018-04057
• Device Sequence Number: 1327130
• Product Code: JWH
• UDI-Device Identifier: 07613327029390
• UDI-Public: 07613327029390
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K030978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

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: 04/30/2016
• Device Catalogue Number: 81-4405R
• Device Lot Number: MKD8DV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/17/2018
• 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
• Patient Age: 59 YR
• Patient Weight: 78