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

Model Number	71420170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Inadequate Osseointegration (2646)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, on (b)(6) 2022 a left tka was performed, and the patient developed incessant pain for one year until their post op checkup on (b)(6) 2023.After procedure, the patient underwent the prescribed six weeks of three times a week physical therapy plus an additional continuation of physical therapy on (b)(6) 2022 and (b)(6) 2022.X rays were taken during the post op check up on (b)(6) 2023, and revealed the separation of the gns ii cmt tib size 6 {} left, so the patient was told a revision would be necessary.The patient also has right knee arthritis, and now has poor balance and requires the use of a cane.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that on (b)(6) 2022, a left tka was performed, and the patient developed incessant pain for one year until their post-operative checkup on (b)(6) 2023.After the procedure, the patient underwent the prescribed six weeks of three times a week physical therapy plus an additional continuation of physical therapy on (b)(6).X-rays were taken during the post op check up on (b)(6) 2023 and revealed the separation of the insert and the tibial component, so the patient was told a revision would be necessary.The status of the patient is unknown.
Additional Manufacturer Narrative
B5: describe event or problem, b7: other relevant history, including preexisting medical conditions, d11: concomitant medical products and therapy dates, e1: initial reporter name and address.Section h3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation; therefore, a device analysis could not be performed.However, the clinical/medical investigation concluded that the images provided and review of the lateral images at 4 months postop (on (b)(6) 2022) already show the reported disassociation of the tibial insert from the baseplate.Later images dated on (b)(6) 2022 as well as on (b)(6) 2023 still show the insert disassociated.Its unknown if any intervention was done prior to on (b)(6) 2023 report of the disassociated insert or if this was noted on previous images.Based on the information provided and an analysis of the x ray images we cannot conclude whether the component separation resulted from a failure to achieve initial fixation.Per communication, the revision surgery has not been scheduled and the patient reports having right knee arthritis, and now has poor balance and requires the use of a cane.No further clinical assessment is warranted at this time.Should additional information become available this issue can be re-elevated.Approved by (b)(6).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 temporary or permanent nerve damage can result in pain or numbness of the affected limb has been identified as a possible adverse effect.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 traumatic injury, joint tightness, patient condition or postoperative care.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 for future complaints and investigate as necessary.We consider this investigation closed.H6: health effect - clinical code and health effect - impact code.

• Brand Name: GNS II CMT TIB SIZE 6 {} LEFT
• 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: 16883090
• Report Number: 1020279-2023-00996
• Device Sequence Number: 5717898
• Product Code: JWH
• UDI-Device Identifier: 03596010206282
• UDI-Public: 03596010206282
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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 Model Number: 71420170
• Device Catalogue Number: 71420170
• Device Lot Number: H2131983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 05/06/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GNS II RESURF PAT 32MM, LOT#: 21FM19035.; LEGION PS OXIN FEM SZ8 LT, LOT#: 21HM18852.; LGN XLPE PS INSERT SZ 5-6 11MM, LOT#: 22AM07825.; SIX WEEKS OF THREE TIMES A WEEK PHYSICAL THERAPY O.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female