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

Catalog Number	3044-0028
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Synovitis (2094)
Date of Event	08/18/2005
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent arthroscopic exam, debridement of the synovium, and lateral release to address patellar impingement.No devices were revised.
Additional Manufacturer Narrative
An event regarding malposition involving a scorpio patella was reported.The event was confirmed via medical review.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: the records were not entirely complete, and no dated or sequential radiographs were provided for review.The patient had a primary knee performed and just over 6 months later had an arthroscopy for the it band and patellar tilt.The records gapped until 2012, when after having pain, the patient had a revision for a loose femur.She did well initially, but 1 ½ years later was seen for pain and instability and ultimately underwent an arthroscopy after an aspiration showed metal stained fluid.She then underwent revision of the femur, and it was found that she had broken the femoral stem at the junction with the threads.It was commented that the failure could represent corrosion.The revision became infected and she underwent a wash out and polyethylene exchange 6 months later.No records were provided for the later claims of another extensor mechanism disruption and revision and/or two stage revision thereafter.No additional materials were presented for review.Event confirmation: two arthroscopy procedures can be confirmed.A revision for a loose femur can be confirmed.A second revision for a loose femur and fracture of a femoral stem can be confirmed.The reason for the stem fracture cannot be confirmed.The two staged revision to competitor components cannot be confirmed.Root cause: the root cause for arthroscopy #1 was anterior knee pain, it band tendonitis and patellar tilt.The cause of the first femoral revision was loosening but a root cause cannot be attributed.The root cause of the second arthroscopy was pain and swelling and presence of metallic debris in aspirated fluid.The root cause of the metal stained fluid was motion at a fractured femoral stem.The root cause of the second revision was femoral loosening and a fractured femoral stem.The root cause of the stem fracture cannot be determined.The root cause of the last procedure, wash out and polyethylene revision, was infection.The root cause of the two stage revision which was not documented would presumed to be infection." product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been 1 other similar event for the lot referenced, for the same device and same patient.Therefore, no lot commonality trend is necessary.Conclusions: it was reported that the patient underwent arthroscopic exam, debridement of the synovium, and lateral release to address patellar impingement.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SCORPIO RECESSED PATELLA
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17928591
• Report Number: 0002249697-2023-01187
• Device Sequence Number: 15061739
• Product Code: JWH
• UDI-Device Identifier: 07613327033793
• UDI-Public: 07613327033793
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K863668
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2023

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: 11/30/2009
• Device Catalogue Number: 3044-0028
• Device Lot Number: R965
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2004
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 113 KG