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

Catalog Number	73-2910
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding infection and loosening involving a scorpio patella was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Clinician review: the available medical records were provided for a review with the consulting clinician which noted, " on (b)(6) 2019 ¿an open debridement and a poly exchange and patellar resurfacing of the right knee¿ was performed for a diagnosis of ¿acutely septic right total knee arthroplasty¿.The operative report describes general anesthesia and a tourniquet time of forty-nine minutes.The report notes, ¿became septic two days ago, also loose patellar component, cloudy turbid fluid, like what was aspirated yesterday, sent for culture and sensitivity, patella backed out, wear was evident, tibial poly, significant wear, tibial tray, no evidence of loosening, irrigated with three liters of antibiotic solution and one liter of betadine solution, then another three liters of antibiotic solution.Changed to another 11/12 cr insert, and a 32 doubled-domed smith & nephew patellar component with antibiotic cement was placed.¿ uncomplicated surgery was described." on an (b)(6) 2019 office visit the note states, ¿pain was noted to be 2 over 10.Patient very satisfied with surgery.0° to 80°, staples removed.Return in four weeks.No documented follow- up subsequent to this visit is available.No examination of explanted components, and there are no culture and sensitivity or bacteriology reports are available for review.There is no indication this septic total knee arthroplasty occurring sixteen years status-post implantation was the result of factors associated with implant design, manufacturing or materials." device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot and sterile lot referenced.Conclusions: it was reported that the patient's knee was revised due to infection.Also as per the medical records, loose patellar component was observed.A review of the available medical records by the consulting clinician noted that no examination of explanted components, and there are no culture and sensitivity or bacteriology reports are available for review.There is no indication this septic total knee arthroplasty occurring sixteen years status-post implantation was the result of factors associated with implant design, manufacturing or materials.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op x- rays, patient history, pathology report & follow-up notes are needed to investigate this event further.The internal investigation of sterilization process and records confirmed the product met sal 10-6 per corresponding iso standards.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
As reported: "painful total right knee.Wash out/ irrigation.Tibial insert and patella swap".Rep indicated that patient was revised to stryker and competitor devices.Update as per medical review, " also loose patellar component, cloudy turbid fluid, like what was aspirated yesterday, sent for culture and sensitivity, patella backed out, wear was evident, tibial poly, significant wear".

• Brand Name: SCORPIO C-DOME 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: 9289846
• Report Number: 0002249697-2019-03713
• Device Sequence Number: 2105320
• Product Code: JWH
• UDI-Device Identifier: 07613327033854
• UDI-Public: 07613327033854
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K962152
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2019

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: 02/28/2007
• Device Catalogue Number: 73-2910
• Device Lot Number: K546
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/07/2019
• 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: 78 YR
• Patient Weight: 92