MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS ART ISRT LG RT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71204524
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to a failed tka.
Additional Manufacturer Narrative
The associated genesis articular insert was not made available for evaluation.Therefore visual inspection and dimensional test could not be performed.However, device details were provided.Thus, a review of device history record and complaint history were performed.The review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.This investigation could not determine a specific cause of failure.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Our clinical evaluation could not performed at this time as no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GNS ART ISRT LG RT 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7967152
• Report Number: 1020279-2018-02188
• Device Sequence Number: 1395363
• Product Code: JWH
• UDI-Device Identifier: 03596010184436
• UDI-Public: 03596010184436
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K871146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2019

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: 04/17/2021
• Device Catalogue Number: 71204524
• Device Lot Number: 11DM12129
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 08/17/2018; 08/17/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 12/06/2018; 05/02/2019
• 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