MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II NON-POR TIB SZ 7 RIGHT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420190
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to loosening of femoral component, patella and tibial baseplate.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis was conducted and the components were inspected visually.No destructive analysis was conducted during this investigation.Bone cement attachment was observed on all of the fixation surfaces of the components with the exception that the tibial baseplate exhibited bone cement attachment on less than half of the fixation surface.Scratching observed on the femoral component was likely due to contact with the tibial baseplate during implantation or removal.Wear, burnishing, and deformation observed on the post of the insert resulted from normal articulation in vivo and which was likely caused due to contact with the femoral cam during expected use in vivo.Wear observed on the articular surfaces of the insert was likely caused by third body debris.No manufacturing deviations were noted during this investigation.A clinical evaluation was conducted and based on the information available, the root cause for the ¿pain and disability¿ stated as the reason for this first revision cannot be concluded.The root cause for second revision was likely the reported infection acquired at the time of the first revision.Without supporting clinical/medical documents a thorough investigation cannot be performed.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.Should information become available this complaint can be re-assessed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GNS II NON-POR TIB SZ 7 RIGHT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8727646
• Report Number: 1020279-2019-02433
• Device Sequence Number: 1807950
• Product Code: JWH
• UDI-Device Identifier: 03596010206374
• UDI-Public: 03596010206374
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: 08/06/2021
• Device Catalogue Number: 71420190
• Device Lot Number: 11EAF0022F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 10/17/2019
• 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