MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO TS TIB INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	72-4-0714
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Fall (1848); Injury (2348); Joint Dislocation (2374)
Date of Event	11/20/2019
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.Device not returned.
Event or Problem Description
The patient required a ts liner change at the same time as an extensor mechanism repair due to instability and recurrent dislocation of the patella tendon, as well as the femur on the insert.The scorpio ts was implanted in 2010, and revised a knee approx 20 years old ( no records avail ).The ts was fine for 4 years, then became unstable after a fall, and started to recurrently dislocate.The pt did not consent to revision surgery until his operation yesterday.The surgeon stated the patients instability was made worse by the fact he had no patella.( previous patellectomy).
Additional Manufacturer Narrative
Correction: device information updated.Implant date updated.An event regarding instability involving a scorpio insert was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection: visual inspection of the returned device noted the following: returned device is fractured along rim.Fracture is consistent with explantation damage.Material analysis: material analysis was not performed because the event does not relate to material integrity.-clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, and additional serial dated x-rays.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion the exact cause of the event could not be determined because insufficient information was provided.Additional information including primary and revision operative reports, clinical and past medical history, additional serial dated x-rays are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
Event or Problem Description
The patient required a ts liner change at the same time as an extensor mechanism repair due to instability and recurrent dislocation of the patella tendon, as well as the femur on the insert.The scorpio ts was implanted in 2010, and revised a knee approx 20 years old ( no records avail ).The ts was fine for 4 years, then became unstable after a fall, and started to recurrently dislocate.The pt did not consent to revision surgery until his operation yesterday.The surgeon stated the patients instability was made worse by the fact he had no patella.( previous patellectomy).

• Brand Name: SCORPIO TS TIB INSERT
• 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: 9488730
• Report Number: 0002249697-2019-04043
• Device Sequence Number: 1385099
• Product Code: JWH
• UDI-Device Identifier: 07613327034462
• UDI-Public: 07613327034462
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K994128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 02/18/2020

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: 04/30/2012
• Device Model Number: 72-4-0714
• Device Catalogue Number: 72-4-0710
• Device Lot Number: 22565501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/18/2020
• 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: 87 YR
• Patient Weight: 76