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

Catalog Number	72-4-0521
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/03/2018
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 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.
Event or Problem Description
It was reported through the submission of a revision implant sheet that patient's right knee was revised.Records from a previous revision, compared to the implant sheet from the (b)(6) 2018 procedure, indicate that a tibial tray and one stem extender (implanted (b)(6) 2008) with a femoral component, insert, augment blocks, and another stem extender (implanted (b)(6) 2015) were revised to a complete ts knee construct as just described with the addition of more augmentation blocks and an offset adapter.Revision was due to instability.The rep has said the baseplate remained implanted.The 13x80 stem remains implanted.The 21x80 stem had to come as it is attached to the femoral component, there was no allegation against the stem or the augments.

• 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: 7646609
• Report Number: 0002249697-2018-01992
• Device Sequence Number: 16531629
• Product Code: JWH
• UDI-Device Identifier: 07613327034417
• UDI-Public: 07613327034417
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K994128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2018

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: 10/31/2016
• Device Catalogue Number: 72-4-0521
• Device Lot Number: MKP1RH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2018
• Initial Report FDA Received Date: 06/28/2018
• 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: 74 YR
• Patient Weight: 67