MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S5-6 9M; PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMI-CONSTRAINED CEMENTED POLY/METAL/POLY

Catalog Number	71421542
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to implant instability.Delay of 30min reported.Replaced with s&n components.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: GII CR DEEP FLEX ISRT S5-6 9M
• Common Device Name: PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMI-CONSTRAINED CEMENTED POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8201144
• Report Number: 1020279-2018-02930
• Device Sequence Number: 2056514
• Product Code: JWH
• UDI-Device Identifier: 03596010496362
• UDI-Public: 03596010496362
• Combination Product (Y/N): N
• PMA/510(K) Number: K041825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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: 04/27/2026
• Device Catalogue Number: 71421542
• Device Lot Number: 16DM21761
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 03/22/2019
• 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