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

Catalog Number 72-25-1110

Device Problems Break (1069); Crack (1135); Fracture (1260); Unstable (1667); Material Integrity Problem (2978)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Injury (2348); Joint Disorder (2373)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the patient's scorpio ps knee replacement was revised due to instability and locking episodes.During the revision it was determined that the ps poly post had fractured and was floating in the anterior aspect of the knee joint.Prior to the revision, patient visited surgeon with complaints of pain, instability and episodes of loss of range of motion and/or locking.

Manufacturer Narrative

An event regarding pain, instability, and episodes of loss of range of motion and/or locking, fractured post involving a scorpio insert was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis was performed and concluded that the "the post of the insert fractured in fatigue from the posterior to the anterior direction.Damage was observed on the posterior surface of the post consistent with contact against the femoral component.Burnishing, delamination, scratching and third-body indentations were observed on the condyles.These are common damage modes of uhmwpe.Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: no patient medical records were 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 investigation concluded with the material analysis examination that "the post of the insert fractured in fatigue from the posterior to the anterior direction.Damage was observed on the posterior surface of the post consistent with contact against the femoral component.Burnishing, delamination, scratching and third-body indentations were observed on the condyles.These are common damage modes of uhmwpe.Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid.No material or manufacturing defects were observed on the surfaces examined.".

Event Description

It was reported that the patient's scorpio ps knee replacement was revised due to instability and locking episodes.During the revision it was determined that the ps poly post had fractured and was floating in the anterior aspect of the knee joint.Prior to the revision, patient visited surgeon with complaints of pain, instability and episodes of loss of range of motion and/or locking.

• Brand Name: SCORPIO-FLEX PS X3 TIB INSERT
• Type of Device: 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6461140
• MDR Text Key: 71754451
• Report Number: 0002249697-2017-01141
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2011
• Device Catalogue Number: 72-25-1110
• Device Lot Number: 2VYMJA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 04/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR