MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG CR FEMORAL COMPONENT RIGHT #8; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	80-4408R
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Injury (2348)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not returned.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to "painful right total knee arthroplasty 2008 secondary to flexion instability and loosening of the tibial component.Severe polyethylene wear lateral tibial plateau of the articular component with associated synovitis".
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to "painful right total knee arthroplasty 2008 secondary to flexion instability and loosening of the tibial component.Severe polyethylene wear lateral tibial plateau of the articular component with associated synovitis".
Additional Manufacturer Narrative
Reported event an event regarding instability/ loosening of baseplate and insert wear involving a scorpio femoral component was reported.Conclusion: it alleged that the patient was revised due to "painful right total knee arthroplasty 2008 secondary to flexion instability and loosening of the tibial component.Severe polyethylene wear lateral tibial plateau of the articular component with associated synovitis".As the baseplate was reported to be loosening and the insert was severely worn which contributes to the reported pain and flexion instability.There is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.A full investigation is completed on the scorpio baseplate and the scorpio insert within the same pi.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: SCORPIO NRG CR FEMORAL COMPONENT RIGHT #8
• 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: 8686460
• Report Number: 0002249697-2019-02197
• Device Sequence Number: 16731719
• Product Code: JWH
• UDI-Device Identifier: 07613327030402
• UDI-Public: 07613327030402
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K042343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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: 02/28/2013
• Device Catalogue Number: 80-4408R
• Device Lot Number: VVDMAE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 08/05/2019
• 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; Required Intervention
• Patient Age: 58 YR