MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 CR TIBIAL INSERT #9 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	82-6-0908
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/04/2018
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 similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Study: total knee replacement left side on (b)(6) 2011.On (b)(6) 2018 patient reports instability due to posterior cruciate insufficiency of the left knee.Knee brace to treat the event.
Event or Problem Description
Study: total knee replacement left side on (b)(6) 2011.On (b)(6) 2018 patient reports instability due to posterior cruciate insufficiency of the left knee.Knee brace to treat the event.
Additional Manufacturer Narrative
An event regarding instability, audible noise and pain as a result of patellar subluxation involving a scorpio insert was reported.The event was confirmed.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: the likely cause of discomfort and ¿click¿ noted on the last office visit of (b)(6) 2018 is a subluxated un-resurfaced patella (natural patella) in the left total knee arthroplasty.There is no evidence this clinical situation is related to the well-fixed and properly situated femoral and tibial components.Device history review: all 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 reported lot.Conclusion: the investigation concluded that the likely cause of discomfort and ¿click¿ noted on the last office visit of (b)(6) 2018 is a subluxated un-resurfaced patella (natural patella) in the left total knee arthroplasty.There is no evidence this clinical situation is related to the well-fixed and properly situated femoral and tibial components.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SCORPIO NRG X3 CR TIBIAL INSERT #9 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: 8117141
• Report Number: 0002249697-2018-03867
• Device Sequence Number: 243786
• Product Code: JWH
• UDI-Device Identifier: 07613327030662
• UDI-Public: 07613327030662
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 82-6-0908
• Device Lot Number: MKJ41A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/16/2019
• 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
• Patient Age: 62 YR
• Patient Weight: 91