MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 35MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420578
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2014, the patient presented right knee pain.A recent x-ray examination highlighted that the patella had displaced and was in superior patella pouch.A revision surgeon was performed: the knee was opened via previous incision, patellar was reviewed and there was noticed that button had sheared off.The patella was resurfaced as per surgical technique.The current state of health in patient is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that a revision was performed due to right knee pain, and an x-ray indicated the patella had displaced.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As batch information was not made available, device history record review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A clinical evaluation noted that to date, the x-rays and op report have been requested but not received.Therefore, the patient impact beyond the revision cannot be determined.Due to the limited information provided, no further clinical assessment is warranted.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to fit/sizing, traumatic injury, abnormal motion over time or patient medical history.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GNS II RESURF PAT 35MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11144583
• Report Number: 1020279-2021-00235
• Device Sequence Number: 11664438
• Product Code: JWH
• UDI-Device Identifier: 03596010208316
• UDI-Public: 03596010208316
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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
• Report Date (Section B): 05/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71420578
• Device Catalogue Number: 71420578
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 01/10/2021
• Supplement Report FDA Received Date: 05/19/2021
• 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