MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS UNI RM/LL XL TIB BASE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	727304
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a total knee revision surgery was performed due to prosthesis mobilization.
Additional 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: GNS UNI RM/LL XL TIB BASE
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8328637
• Report Number: 1020279-2019-00520
• Device Sequence Number: 16194702
• Product Code: HSX
• UDI-Device Identifier: 03596010257314
• UDI-Public: 03596010257314
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K912735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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: 04/22/2023
• Device Catalogue Number: 727304
• Device Lot Number: 13DM16769
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/02/2019
• 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