MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 CR TIBIAL INSERT #9 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	82-6-0908
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Date of Event	11/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted on into final stock with no reported discrepancies.There have been no other events for the lot referenced.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.The following devices were also listed in this report: scorpio nrg cr femoral component right# 11, cat# 80-4411r, lot# mjt82y.Series 7000 standard tibia, cat# 7115-0009, lot# mkhnt1.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not available.
Event or Problem Description
Study states: patient reports pain, numbness right side of the operated knee.Treatment: medication, tens.No revision of device.
Additional Manufacturer Narrative
An event regarding pain involving a scorpio insert was reported.The event was confirmed through medical review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Clinician review: conclusion of assessment nerve injury to the infrapatellar branch of the saphenous nerve during primary arthroplasty has contributed to local neuroma formation with pain and numbness on the anterior side of the knee.Conservative treatment was successful without indication for revision surgery.Does the review identify any procedural related factors that contributed to the event?- surgical damage to the infrapatellar branch of the saphenous nerve during incision for primary total knee arthroplasty.Does the review identify any patient related factors that contributed to the event? none.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.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 have been no other similar events for the lot referenced.Conclusions: the investigation concluded that nerve injury to the infrapatellar branch of the saphenous nerve during primary arthroplasty has contributed to local neuroma formation with pain and numbness on the anterior side of the knee.Conservative treatment was successful without indication for revision surgery.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
Study states: patient reports pain, numbness right side of the operated knee.Treatment: medication, tens.No revision of device.

• Brand Name: SCORPIO NRG X3 CR TIBIAL INSERT #9 8MM
• 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: 8245501
• Report Number: 0002249697-2019-00174
• Device Sequence Number: 11355491
• Product Code: JWH
• UDI-Device Identifier: 07613327030662
• UDI-Public: 07613327030662
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 82-6-0908
• Device Lot Number: MKJA9T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 03/22/2019
• 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
• Patient Age: 76 YR
• Patient Weight: 96