MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S3-4 13M; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMER/METAL

Catalog Number	71421538
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to patient presented stiffness and pain.Polyethylene insert was replaced for a thinner component.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.It was reported that a revision surgery was performed due to pain and stiffness approximately four and a half years post implantation.It was further reported that the surgeon was concerned that the poly insert has disengaged, and it was therefore exchanged with a thinner component.The batch number is unknown.Additionally, there are no patient medical records or radiographs to be provided for review.Based on insufficient information, a clinical assessment cannot be performed at this time.Without the actual product involved, our investigation cannot proceed.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Based on this investigation, the need for corrective action is not indicated.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GII CR DEEP FLEX ISRT S3-4 13M
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7166559
• Report Number: 1020279-2018-00027
• Device Sequence Number: 16620169
• Product Code: JWH
• UDI-Device Identifier: 03596010512468
• UDI-Public: 03596010512468
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K041825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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 Catalogue Number: 71421538
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 04/10/2018
• 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