MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN UNI ART INSRT XL-MG 8 MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 71248338

Device Problem Migration (4003)

Patient Problem Injury (2348)

Event Date 01/11/2019

Event Type  Injury  

Event Description

It was reported that a total knee revision surgery was performed due to prosthesis mobilization.

Manufacturer Narrative

The associated oxinium uni femoral component, genesis uni tibial baseplate and genesis uni articular insert were not returned for evaluation.The devices were manufactured in 2013.Device details were provided.Thus, our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A clinical analysis noted that no relevant clinical supporting documents were provided to conduct a thorough analysis of the reported issue.Therefore, no clinical/medical assessment can be rendered at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: GEN UNI ART INSRT XL-MG 8 MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8328744
• MDR Text Key: 135852191
• Report Number: 1020279-2019-00521
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010500731
• UDI-Public: 03596010500731
• Combination Product (y/n): N
• PMA/PMN Number: K912735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2023
• Device Catalogue Number: 71248338
• Device Lot Number: 13BM15187
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention