MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 29MM; PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY

Model Number	71420574
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to wear on the patella.No further information reported.
Event or Problem Description
It was reported that, after a navio-assisted pfa had been performed on the right side, the patient experienced synovitis and pain.The adverse event was treated with arthroscopic synovectomy; in such surgery, the patella was found to be damaged and probably caused synovitis to the unstable patellofemoral component.The patient is able to mobilise post-operatively.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device has signs of damage from implantation / extraction.The device has a large amount of cement adhered to the mating surface.The device also has a large worn section in the articular surface.The clinical/ medical evaluation concluded that, per complaint details, the patient experienced synovitis and pain several months post right navio-assisted pfa.Reportedly, an arthroscopic synovectomy was performed, during which ¿the patella was found to be damaged and probably caused synovitis to the unstable patellofemoral component¿.Responses to the requested documentation/clinical information were not provided as of the date of this assessment.Based on the information provided the impact beyond the reported symptoms and interventions could not be definitively determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include a traumatic injury, fit/ sizing issue or procedural error.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device has signs of damage from implantation / extraction.The device has a large amount of cement adhered to the mating surface.The device also has a large worn section in the articular surface.The clinical/ medical evaluation concluded that, per complaint details, the patient experienced synovitis and pain several months post right navio-assisted pfa.Reportedly, an arthroscopic synovectomy was performed, during which ¿the patella was found to be damaged and probably caused synovitis to the unstable patellofemoral component¿.Responses to the requested documentation/clinical information were not provided as of the date of this assessment.Based on the information provided the impact beyond the reported symptoms and interventions could not be definitively determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.No batch information available or legible on the device, dhr task was unable to be performed.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include a traumatic injury, fit/ sizing issue or procedural error.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GNS II RESURF PAT 29MM
• Common Device Name: PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10422402
• Report Number: 1020279-2020-04012
• Device Sequence Number: 2990949
• Product Code: JWH
• UDI-Device Identifier: 03596010208293
• UDI-Public: 03596010208293
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2021

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 Model Number: 71420574
• Device Catalogue Number: 71420574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 06/24/2021; 07/28/2021
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 06/28/2021; 08/04/2021
• 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
• Patient Age: 60 YR