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 Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021 a washout of a tkr was performed due to pain and inflammation, infection was not confirmed but the patellar button was loosened and the polyethylene was also explanted.The current health status of the patient is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.The images provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, per the complaint, no relevant clinical information will be provided for inclusion in this medical investigation.Without the requested clinical information, a thorough medical investigation cannot be rendered nor can the root cause of the reported failure be determined.Based on the information provided, a washout of a tkr was performed due to pain and inflammation.Although it was reported the infection was not confirmed, the patellar button was loose, and the polyethylene was also explanted.The impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this complaint will be re-assessed.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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 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: 12145188
• Report Number: 1020279-2021-05878
• Device Sequence Number: 3976114
• Product Code: JWH
• UDI-Device Identifier: 03596010208316
• UDI-Public: 03596010208316
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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: 18EM17522
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/20/2021
• 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