MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421516
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery (left) was performed on (b)(6) 2006, the patient had an infection.This adverse event was treated by a revision surgery on (b)(6) 2023,in which the surgeon performed a washout and replaced the gii ps hi flex isrt sz 5-6 11.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, a bilateral insert revision with washout was performed approximately 16-17 years post bilateral tka due to an unspecified infection.It was communicated that the requested medical documentation would not be provided; therefore, clinical factors (and/or source of the infection) which could have contributed to the reported event could not be definitively concluded and a causal relationship could not be confirmed.However, due to the length of time in-vivo and bilateral revision/washout, hematogenous dissemination of an infection cannot be ruled out.The patient impact beyond the reported unspecified infection and bilateral insert revision with washout could not be determined.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed a similar event for the listed device.A review of the instructions for use documents for knee systems revealed that acute post-surgical wound infection has been identified in possible adverse effects.Active, local infection or previous intra-articular infections are identified in contraindications for total knee replacement.A review of the risk management file 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 this product and event.Additionally, since the device batch number was not provided, a review of the sterilization records could not be performed.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.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: GII PS HI FLEX ISRT SZ 5-6 11
• 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: 17950840
• Report Number: 1020279-2023-01962
• Device Sequence Number: 6790080
• Product Code: JWH
• UDI-Device Identifier: 03596010492333
• UDI-Public: 03596010492333
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2023
• 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): 11/09/2023

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 Catalogue Number: 71421516
• Device Lot Number: UNKNOWN
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown