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
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); Unspecified Mental, Emotional or Behavioural Problem (4430); Implant Pain (4561)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• 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: 18383351
• Report Number: 1020279-2023-02558
• Device Sequence Number: 7712936
• Product Code: JWH
• UDI-Device Identifier: 03596010209894
• UDI-Public: 03596010209894
• 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: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2025
• Device Catalogue Number: 71420884
• Device Lot Number: 15KM05221
• 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: 11/27/2023
• Supplement Date Received by Manufacturer: 01/23/2024; 01/23/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/24/2024; 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2015
• 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: 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)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown