MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXIN P/S FEM RIGHT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421117
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tkr surgery was performed on (b)(6) 2014, in which a gii oxin p/s fem right sz 7, a gns ii cem tib size 8 right and a gii ps hi flex isrt sz 7-8 11 were implanted, the patient experienced anterior knee pain.The physician decided to perform an additional surgery to resurface the patella on (b)(6) 2024.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Section h3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that the complaint form documented that no parts were explanted but the operative reports and radiological imaging were not available.Disease progression is a known occurrence and cannot be ruled out as a contributing factor to the reported event.Although it has been advocated that resurfacing the patella during primary total knee arthroplasty should be considered as a routine adjunct to total knee arthroplasty, it is not indicative of a component malperformance.The patient impact beyond the onset of anterior knee pain with subsequent adjunct patellar resurfacing cannot be determined; however, no components were revised/explanted.A review of the production orders for the femoral component and tibial baseplate did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.As the provided insert's part and batch number information did not match into the system, a device history record review could not be performed.A review of complaint history for the part number of the femoral component and tibial baseplate over the past 12 months and for their batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of complaint history of the insert for the previous 12 months did not reveal similar events for the listed device.As previously mentioned, the provided batch number of the insert is not valid within the system, however the review was performed and did not reveal similar events.A review of the instructions for use documents for knee systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or disease progression.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: GII OXIN P/S FEM RIGHT SZ 7
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18988571
• Report Number: 1020279-2024-00632
• Device Sequence Number: 8405745
• Product Code: JWH
• UDI-Device Identifier: 03596010469311
• UDI-Public: 03596010469311
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K962557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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: 03/31/2024
• Device Catalogue Number: 71421117
• Device Lot Number: 14CM08785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71420191/13GT32498/GNS II CEM TIB SIZE 8 RIGHT; 71421523/42099/GII PS HI FLEX ISRT SZ 7-8 11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown