MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 PS TIBIAL INSERT #11 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	82-7-1110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.
Event or Problem Description
Scorpio nrg ps poly exchange from original surgery.Update: as reported in how was issue noticed: during the doctor's clinical evaluation.Patient states knee is "locking".As reported in adverse consequences details: patient had a revision surgery to exchange a broken ps poly post.
Event or Problem Description
Scorpio nrg ps poly exchange from original surgery.Update: as reported in how was issue noticed: during the doctor's clinical evaluation.Patient states knee is "locking".As reported in adverse consequences details: patient had a revision surgery to exchange a broken ps poly post.
Additional Manufacturer Narrative
An event regarding crack/fracture of the post of a scorpio tibial ps insert was reported.Clinician review of the medical records provided confirmed the event but could not determine a root cause.Method & results: product evaluation and results: the device was not returned however one photo was provided of the explanted device.The photo shows a fracture of stabilizing ps post.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms the reported broken post.Need patient demographics, operative reports, clinical reports, histopathology reports, office notes, serial x-rays and examination of the explanted components.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there were no other events for the lot provided.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms the reported broken post.The root cause of the fracture of the post of the insert is not identified.Further information such as patient demographics, operative reports, clinical reports, histopathology reports, office notes, serial x-rays and examination of the explanted components.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SCORPIO NRG X3 PS TIBIAL INSERT #11 10MM
• 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: 8190402
• Report Number: 0002249697-2018-04112
• Device Sequence Number: 13928449
• Product Code: JWH
• UDI-Device Identifier: 07613327031201
• UDI-Public: 07613327031201
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2014
• Device Catalogue Number: 82-7-1110
• Device Lot Number: MHLHDT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 02/07/2019
• 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; Other; Required Intervention
• Patient Age: 76 YR