MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II POROUS P/S FEM SZ4 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 71420884

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); Unspecified Mental, Emotional or Behavioural Problem (4430); Implant Pain (4561)

Event Date 11/27/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference (b)(4).Note - first revision surgery due to allergic reaction (benzoyl peroxide) reported to fda under manufacturer report number 1020279-2023-02556.

Event Description

It was reported that, after undergoing tka revision surgery on (b)(6) 2020 due to an allergic reaction to benzoyl peroxide, the patient experienced pain and declining mental health, for which a second revision surgery was performed on (b)(6) 2023 to replace all the previous implants.It was observed that there was no bone ingrowth on the femoral component.Patient's current health status is recovering.

Manufacturer Narrative

The reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the genesis ii porous posterior stabilized femoral.Therefore, no investigation is deemed for the other devices.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the noted radiolucency under the femoral component on the (b)(6) 2023 x-ray image likely indicates insufficient bony integration into the porous implant which would contribute to the patient¿s reported pain and appears congruent with the complaint.Additionally, it was alleged there was an ¿extended lead time¿ after the surgeon initiated correspondence for a custom implant (revision performed on (b)(6) 2023), which reportedly contributed to the patient¿s mental health decline.The patient impact included the radiolucency/insufficient bony integration, pain, and reported mental health decline.Since no details/documentation were provided regarding the patient¿s mental health, further assessment is not possible; however, it was communicated that the patient is ¿doing well¿ and ¿is now very happy¿ with the current revision.Further impact cannot be determined.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that revealed that looseness of components has been identified in possible adverse effects section as a result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.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.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 abnormal loading of limb, alignment, patient anatomy, procedural/user error and/or traumatic injury.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: GNS II POROUS P/S FEM SZ4 RT
• Type of Device: 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: 18383351
• MDR Text Key: 331211316
• Report Number: 1020279-2023-02558
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010209894
• UDI-Public: 03596010209894
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K951987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71420884
• Device Lot Number: 15KM05221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/23/2024; 01/23/2024
• Supplement Dates FDA Received: 01/24/2024; 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GII FMRL FLX PGS(PN:71420063,LN:13FM08194); LGN H FLX XLP SZ3-4 9MM(PN:71453111,LN:19MM13548); LGN PRS TBL BS SZ3 RT(PN:71934062,LN:17JM18880A); PRO MT TIB STEM20MM(PN:71501020,LN:16HTX0011A)
• Patient Outcome(s): Required Intervention; Hospitalization