MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II POR FEM SIZE 6 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 71420042

Device Problem Loss of Osseointegration (2408)

Patient Problems Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Inadequate Osseointegration (2646); Implant Pain (4561)

Event Date 12/16/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference (b)(4).B5- the mentioned first revision surgery conducted in 2002 was reported to fda under manufacturer report number 1020279-2024-00083.D6a: exact implantation date is unknown; it was placed back in 2002.

Event Description

It was reported that, after a tka revision surgery was performed on 2002, the patient experienced severe pain when standing.The patient went to emergency and was admitted to hospital.An mri scan revealed a large cyst on the lateral femoral condyle, and it was noticed that the femoral component started to collapse.This adverse event was treated by performing a second revision surgery on (b)(6) 2023, in which the gns ii por fem size 6 left was confirmed to be loose.A new legion femoral component was placed, along with a new tka system.Patient's current health status is unknown.

Manufacturer Narrative

H10: updated section h6 (clinical code).H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that the instructions for use document in the possible adverse events section does address the duration of service and possibility of future revision due to a variety of contributing factors; therefore, the length of time in-vivo could not be ruled out as a potential contributing factor in the presence of the cyst and femoral collapse findings in the patient with an elevated body mass index.No permission received for medical documentation per complaint form.Patient impact beyond the severe pain with the loosened femoral component in the presence of a large cyst with component collapse and subsequent revision cannot be determined.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that looseness of components could occur 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.Additionally, temporary or permanent nerve damage can result in pain or numbness of the affected limb.These have been identified as possible adverse effects.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, length of time in-vivo and/or patient condition.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 POR FEM SIZE 6 LEFT
• 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: 18499407
• MDR Text Key: 332725563
• Report Number: 1020279-2024-00084
• Device Sequence Number: 1
• Product Code: JWH
• 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
• Report Date: 02/12/2024

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: 71420042
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Female