MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO M-DOME X3 PATELLA; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	73-20-0510
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Codes	Fall (1848); Injury (2348)
Date of Event	06/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding alleged instability and crack/fracture involving a scorpio patella was reported.The event was confirmed.Method & results: product evaluation and results: a visual, functional and dimensional inspection could not be performed as the product remained implanted.Clinician review: a review of the provided medical records was performed by the consulting clinician indicated "on (b)(6) 2017 a left knee revision total knee arthroplasty with changing the poly to increase constraint with a metal post was performed for a diagnosis of "left knee instability status-post left tka, and left knee patellar fracture." the operative report describes spinal anesthesia and a tourniquet time of fifty minutes.The report notes, ".Past three to six months knee increasingly unstable.Noted tibial post was fractured and floating in the notch of the knee joint.Changed to a #9/16 scorpio ts insert with excellent stability and motion.Patella.Small fragment of fracture.Healed over the lateral facet.Patella very stable." the patellar component was retained and uncomplicated surgery was described, and the patient was discharged home on (b)(6) 2017." "no examination of the explanted tibial insert and the ps post fracture surfaces are available." "in this large, male patient with multiple systems and polyarticular problems, inadequate soft tissue balancing at the primary surgery would stress the ps post to function as a stabilizer on weightbearing rather than acting as a cam to direct motion.This could lead to fatigue fracture at the base of the post, which could be confirmed by examining the fracture surfaces and ruling out manufacturing or material factors on examination of the component as having contributed to this event.The incidental small lateral patellar facet fracture was likely related to devascularization of the small patellar component and soft tissue imbalance as noted on the (b)(6) 2015 x-ray demonstrating lateral patellar subluxation.An additional revision surgery of the left knee is alluded to on two emergency room visits of (b)(6) 2016 and (b)(6) 2016 for abdominal pain suggesting the additional surgery was performed in mid-(b)(6) 2016.No operative reports or documentation of this alleged surgery is available for review." device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event was confirmed.However the exact cause of the event could not be determined because the device was not returned and insufficient information was provided.If devices and / or additional information become available, this investigation will be reopened.
Event or Problem Description
Patient reported he had a triathlon knee surgery in 2010 and has been experiencing issues for the past year and half.The majority of the issue has been falling without any indication.On the first of december the patient had exploratory knee surgery in which the surgeon discovered the polyethylene articulating surface had broken.Patient has surgical images of the device.Event update: on (b)(6) 2017 a left knee revision total knee arthroplasty with changing the poly to increase constraint with a metal post was performed for a diagnosis of "1.Left knee instability status-post left tka, and 2.Left knee patellar fracture."[.]the report notes, ".Past three to six months knee increasingly unstable.Noted tibial post was fractured and floating in the notch of the knee joint.Changed to a #9/16 scorpio ts insert with excellent stability and motion.Patella.Small fragment of fracture.Healed over the lateral facet.Patella very stable." the patellar component was retained and uncomplicated surgery was described.".

• Brand Name: SCORPIO M-DOME X3 PATELLA
• 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: 8595209
• Report Number: 0002249697-2019-01899
• Device Sequence Number: 16717710
• Product Code: JWH
• UDI-Device Identifier: 07613327014471
• UDI-Public: 07613327014471
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K051977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2019

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: 01/31/2020
• Device Catalogue Number: 73-20-0510
• Device Lot Number: 56RX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/09/2019
• 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: 113