MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO-FLEX PS X3 TIB INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	72-25-1110
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that patient examination showed the femur subluxing anteriorly around 100 degrees of flexion and then reducing back into position around 45 degrees of flexion.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a scorpio ps insert was reported.The event was confirmed by medical review and product inspection.Method & results: -device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 16-dec-2019.This inspection indicated that the post of the tibial insert fractured, the fracture piece was returned.Damage was observed on this distal side of the insert consistent with explantation.Backside impressions were observed on the distal side of the insert consistent with contact against a tibial baseplate.Damage was observed on the articulating surface of the insert, consistent with contact against the femoral component.Damage on the articulating surface was consistent with burnishing, scratching, and third body indentations; these are common damage modes of uhmwpe.Material loss consistent with edge loading from contact against the femoral component was observed on the insert.Yellow discoloration consistent with absorption of synovial fluid was also observed on the insert.A material analysis has been performed.The report indicated that the fracture surface was obscured by post fracture abrasion.The fracture surface morphology is consistent with a fatigue fracture initiating on the posterior surface and propagating anteriorly.The reported concluded that the tibial post fractured in fatigue with the fracture initiating on the posterior surface and propagating anteriorly.The damage present on articulating surface of the insert is consistent with contact against the femoral component, material loss was also observed.Yellow discoloration consistent with absorption of synovial fluid was observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: provided image shows ps insert with broken post.Need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-device history review: -complaint history review: there has been 1 other similar event for the reported lot.Trend 1305 has been submitted for this lot commonality.Conclusion: material analysis concluded that the tibial post fractured in fatigue with the fracture initiating on the posterior surface and propagating anteriorly.The damage present on articulating surface of the insert is consistent with contact against the femoral component, material loss was also observed.Yellow discoloration consistent with absorption of synovial fluid was observed on the insert.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Additional information including primary and revision operative reports, clinical and past medical history and additional serial dated x-rays are needed to fully investigate the event.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that patient examination showed the femur subluxing anteriorly around 100 degrees of flexion and then reducing back into position around 45 degrees of flexion.

• Brand Name: SCORPIO-FLEX PS X3 TIB INSERT
• 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: 9221087
• Report Number: 0002249697-2019-03581
• Device Sequence Number: 19389036
• Product Code: JWH
• UDI-Device Identifier: 07613327029802
• UDI-Public: 07613327029802
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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: 10/31/2011
• Device Model Number: 72-25-1110
• Device Catalogue Number: 72-25-1110
• Device Lot Number: 11MJA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 03/16/2020
• 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: 77 YR