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

Catalog Number	71420188
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Joint effusion (4849)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2022, the patient experienced pain and joint effusion.This adverse event was solved by revision surgery for loosening on (b)(6) 2023, in which it was noticed that there was a complete de-bonding of the gns ii cmt tib size 6 right from the cement mantle, no infection suspected/indicated.The gns ii cmt tib size 6 right was explanted.Current health status of patient is recovering from revision tka.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals multiple scratches, gouges and discoloration on the device.These issues could be from the insertion attempt or removal attempt.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that as of the date of this medical investigation, the requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported loosening and subsequent revision.The provided photos were reviewed, but do not aid in determining a clinical root cause for the reported pain and joint effusion.It is noted, ¿it was noticed that there was a complete de-bonding of the gns ii cmt tib size 6 right from the cement mantle.¿ the provided implant photo appears void of cement.With the limited information provided, the patient impact beyond the reported revision cannot be determined.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management and information for use files revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A review of instructions for use for knee systems revealed in possible adverse effects that looseness of components has been identified 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.Also, revealed that temporary or permanent nerve damage can result in pain or numbness of the affected limb.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, size selected, inadequate integration between the cement and bone/implant, osteolysis and/or traumatic injury.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 future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
The device was not returned for evaluation.However, the photographs were reviewed and did not reveal any defects.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported loosening and subsequent revision.The provided photos were reviewed, but do not aid in determining a clinical root cause for the reported pain and joint effusion.It is noted, ¿it was noticed that there was a complete de-bonding of the gns ii cmt tib size 6 right from the cement mantle.¿ the provided implant photo appears void of cement.With the limited information provided, the patient impact beyond the reported revision cannot be determined.No further clinical assessment is warranted at this time.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed in possible adverse effects that looseness of components has been identified 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.Also, revealed that temporary or permanent nerve damage can result in pain or numbness of the affected limb.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 motion over time, bone degeneration, inadequate integration between the cement and bone/implant, osteolysis 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 CMT TIB SIZE 6 RIGHT
• 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: 17780578
• Report Number: 1020279-2023-01796
• Device Sequence Number: 12420660
• Product Code: JWH
• UDI-Device Identifier: 03596010206367
• UDI-Public: 03596010206367
• 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: 2022
• 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,Followup
• Report Date (Section B): 11/20/2023

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: 71420188
• Device Lot Number: 21LB00295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 10/24/2023; 11/06/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 10/25/2023; 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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