MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 PS TIBIAL INSERT #5 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	82-7-0510
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
During revision surgery in (b)(6) 2019 the possibility that the locking posterior of the insert was off by x-p was recognized.Additional info at (b)(6) 2019: the revision surgery is planned at (b)(6) 2019.This pi is for the right side of the knee.
Additional Manufacturer Narrative
An event regarding a seating/locking issue involving a scorpio insert was reported.The event was confirmed through review of the provided medical records and x-rays by a clinical consultant.Method & results: -device evaluation and results: -visual inspection the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted scorpio insert.From the photographs provided there was no obvious damage noted material analysis, dimensional and functional inspections were not performed as no devices were returned.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated "incomplete locking of the tibial bearing in the baseplate during primary right knee arthroplasty in may 2015, due to inadequate clearance of the posterior joint space from bone pieces, has contributed to bearing revision in jan 2019 about which no further info is available.Does the review identify any procedural related factors that contributed to the event? - incomplete locking of the tibial bearing in the baseplate during primary right knee arthroplasty through inadequate clearance of the posterior joint space from bone pieces does the review identify any patient related factors that contributed to the event? - none, but body weight is unknown does the review identify any device related factors that caused or contributed to the adverse event? - no device-related factors are associated with any of the implanted devices." -device history review: a product history review could not be performed as no lot information was provided.-complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: a clinician review of the provided medical records states the following; "incomplete locking of the tibial bearing in the baseplate during primary right knee arthroplasty in may 2015, due to inadequate clearance of the posterior joint space from bone pieces, has contributed to bearing revision in jan 2019 about which no further info is available.Does the review identify any procedural related factors that contributed to the event? - incomplete locking of the tibial bearing in the baseplate during primary right knee arthroplasty through inadequate clearance of the posterior joint space from bone pieces does the review identify any patient related factors that contributed to the event? - none, but body weight is unknown does the review identify any device related factors that caused or contributed to the adverse event? - no device-related factors are associated with any of the implanted devices." the exact cause of the event could not be determined because insufficient information was provided.Additional information including return of the device, operative reports, clinical reports, histopathology reports, office notes and serial x-rays are needed to fully investigate the event.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
During revision surgery in (b)(6) 2019, the possibility that the locking posterior of the insert was off by x-p was recognized.Additional info at 2019/jan/31: the revision surgery is planned at (b)(6) 2019/.This pi is for the right side of the knee.

• Brand Name: SCORPIO NRG X3 PS TIBIAL INSERT #5 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: 8337601
• Report Number: 0002249697-2019-01047
• Device Sequence Number: 1500853
• Product Code: JWH
• UDI-Device Identifier: 07613327030938
• UDI-Public: 07613327030938
• Combination Product (Y/N): N
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 04/24/2019

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 Catalogue Number: 82-7-0510
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 04/24/2019
• 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: Other