MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 CR TIBIAL INSERT #7 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	82-6-0710
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2023
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 similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text : not returned to the manufacturer.
Event or Problem Description
Revision knee.Left scorpio nrg cr x3.Operation was poly change, for wear.Size 8l femur.Size 7 tibia.7-10mm nrg cr x3 poly.Surgeon would like the wear on the cr x3 poly investigated.Medial side in particular, deeper white area.
Event or Problem Description
Revision knee.Left scorpio nrg cr x3.Operation was poly change, for wear.Size 8l femur.Size 7 tibia.7-10mm nrg cr x3 poly.Surgeon would like the wear on the cr x3 poly investigated.Medial side in particular, deeper white area.
Additional Manufacturer Narrative
Reported event an event regarding wear involving a scorpio insert was reported.The event was confirmed.Method & results -product evaluation and results: visual inspection: damage consistent with the explantation process was observed on the anterior surface of the implant.Burnishing, scratching, delamination, and third body indentations were observed on the articulating surface which are common damage modes of uhmwpe.The aforementioned damage modes are consistent with contact against the femoral component.Yellow discoloration consistent with the absorption of synovial fluid was also observed.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar evets for lot referenced.Conclusions: it was reported that the patient was revised due to insert wear.Visual inspection: damage consistent with the explantation process was observed on the anterior surface of the implant.Burnishing, scratching, delamination, and third body indentations were observed on the articulating surface which are common damage modes of uhmwpe.The aforementioned damage modes are consistent with contact against the femoral component.Yellow discoloration consistent with the absorption of synovial fluid was also observed.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SCORPIO NRG X3 CR TIBIAL INSERT #7 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 17904120
• Report Number: 0002249697-2023-01167
• Device Sequence Number: 15428198
• Product Code: JWH
• UDI-Device Identifier: 07613327030648
• UDI-Public: 07613327030648
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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: 03/31/2020
• Device Catalogue Number: 82-6-0710
• Device Lot Number: 4D265K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female