MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 PS TIBIAL INSERT #5 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	82-7-0508
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
At revision surgery in (b)(6) 2019, the possibility that the locking posterior of the insert was off by x-p was recognized.Additional info at (b)(6) 2019: the revision surgery is planned at (b)(6) 2019.Reported under another pi for the other knee.

• Brand Name: SCORPIO NRG X3 PS TIBIAL INSERT #5 8MM
• 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: 8337675
• Report Number: 0002249697-2019-01048
• Device Sequence Number: 11155930
• Product Code: JWH
• UDI-Device Identifier: 07613327030969
• UDI-Public: 07613327030969
• Combination Product (Y/N): N
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 82-7-0508
• Device Lot Number: 2A2JTY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 02/13/2019
• 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: Other