MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS PROXIMAL TIBIAL STANDARD; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64953102
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/04/2018
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
The doctor reported to sales rep an interaction of gmrs prosthesis with the electromagnetic field during mri scanning of the patient.
Event or Problem Description
The doctor reported to sales rep an interaction of gmrs prosthesis with the electromagnetic field during mri scanning of the patient.
Additional Manufacturer Narrative
An event regarding interaction of an implant with the electromagnetic field during mri scanning involving a gmrs tibial component was reported.Based on the provided information the event reported is considered an off-label event.A review of packaging insert 0095-3-210, rev aa noted the following: precautions mr.Surgeons should warn patients with metallic implants of the potential risks of undergoing a magnetic resonance imaging (mri) scan.The electromagnetic field created by an mri scanner can interact with the metallic implant, resulting in displacement of the implant, heating of the tissue near the implant, implant damage or malfunction, or other undesirable effects.In addition, the presence of a metallic implant can produce an image artifact that may appear as a void region or geometric distortion of the true image.If the image artifact is near the area of interest, it may make the mri scan uninformative or may lead to inaccurate clinical diagnosis or treatment.Interaction with magnetic resonance imaging the stryker joint systems have not been evaluated for safety and compatibility in the mr environment.The stryker joint systems have not been tested for heating or migration in the mr environment.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: GMRS PROXIMAL TIBIAL STANDARD
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8027617
• Report Number: 0002249697-2018-03574
• Device Sequence Number: 16193908
• Product Code: KRO
• UDI-Device Identifier: 07613327048865
• UDI-Public: 07613327048865
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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: 12/31/2020
• Device Catalogue Number: 64953102
• Device Lot Number: 155908C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 01/02/2019
• 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