MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 PS TIBIAL INSERT #11 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	82-7-1115
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other 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.Device not returned.
Event or Problem Description
Left knee poly exchange.Update 02/october/2018: as reported in how was issue noticed: "approximately 10 years after implant.Patient has positive posterior instability".Explant picture provided by the rep.
Event or Problem Description
Left knee poly exchange.Update 02/october/2018: as reported in how was issue noticed: "approximately 10 years after implant.Patient has positive posterior instability".Explant picture provided by the rep.
Additional Manufacturer Narrative
Reported event: an event regarding instability and crack/fracture involving a scorpio tibial insert was reported.Medical review confirmed the event but could not determine a root cause.Method & results: -product evaluation and results: the device was not returned however one photo was provided of the explanted device.The photo shows a fracture of stabilizing ps post.It also shows some biological material on the device.-medical records received and evaluation: a review of the provided x-rays and explant photos by a clinician noted the following: it was reported that approximately 10 years after tka implantation that the patient developed posterior instability requiring revision surgery.A single ap and lateral x-ray of the knee was available for review.These x-rays demonstrate a cemented left cruciate retaining tka in anatomic position.The implants are in normal alignment and appear well fixed without evidence of loosening or mechanical complication.A photograph of the explanted ps polyethylene liner shows that the stabilizing ps post had fractured.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there were no other events for the lot provided.Conclusions: the medical review concluded the following: the event of posterior instability requiring revision surgery of a tka implanted in 2009 is confirmed.The cause of the posterior instability is fracture of the stabilizing ps post of a ps polyethylene tibial insert.The root cause of the fracture of the post of the insert is not identified.Documentation which would aid in the further completion of this assessment would include: ¿ operative reports ¿ dated pre and post op x-rays/ imaging from the index and revision surgeries ¿ outpatient office/clinic notes ¿ implant retrieval with material analysis no further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SCORPIO NRG X3 PS TIBIAL INSERT #11 15MM
• 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: 7991287
• Report Number: 0002249697-2018-03454
• Device Sequence Number: 13896616
• Product Code: JWH
• UDI-Device Identifier: 07613327031256
• UDI-Public: 07613327031256
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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: 03/31/2013
• Device Catalogue Number: 82-7-1115
• Device Lot Number: PRTMDE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 01/17/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 100