MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 PS TIBIAL INSERT #5 8MM; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number	82-7-0508
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that: admitted hyper extensibility to patient who took tka in 2016.The post of the insert was broken from the base and the insert was replaced at (b)(6) 2018.The doctor requested that what kind of power has been added and broken.
Event or Problem Description
It was reported that: admitted hyper extensibility to patient who took tka in 2016.The post of the insert was broken from the base and the insert was replaced at (b)(6) 2018.The doctor requested that what kind of power has been added and broken.
Additional Manufacturer Narrative
An event regarding crack/fracture of the ps post involving a scorpio insert was reported.The event was confirmed based on evaluation of the returned device.A material analysis was performed on the returned device and concluded that the insert fractured at the post.The fracture initiated in overload, propagated in fatigue, and the final fracture occurred in overload.Burnishing, scratching and third-body indentations were observed on the insert condyles.These are common damage modes of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: not performed as medical records were not provided for review.All devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.A material analysis was performed on the returned device and concluded that the insert fractured at the post.The fracture initiated in overload, propagated in fatigue, and the final fracture occurred in overload.Burnishing, scratching and third-body indentations were observed on the insert condyles.These are common damage modes of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Further information such as patient details, operative notes, orthopedic clinic notes and x-rays would be required to determine the root cause for this event.If additional information becomes available, this investigation will be reopened.

• Brand Name: SCORPIO NRG X3 PS TIBIAL INSERT #5 8MM
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7793804
• Report Number: 0002249697-2018-02568
• Device Sequence Number: 16466454
• Product Code: JWH
• UDI-Device Identifier: 07613327030969
• UDI-Public: 07613327030969
• Combination Product (Y/N): N
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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: 04/30/2021
• Device Catalogue Number: 82-7-0508
• Device Lot Number: 1V6XV6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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