MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 3 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420182
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference:(b)(4).
Event or Problem Description
It was reported that, after total knee arthroplasty was performed on an unknown date, the patient experienced pain after standing 20 minutes.An mri showed that the legion xlpe ps insert size 3-4 9mm was not fully seated on the gns ii cmt tib size 3 right (which might have been damaged at some point).This adverse event was treated with a revision surgery on (b)(6) 2022.Soft tissues that may have been interfering with the locking mechanism were removed.A genesis ii constrained articular insert size 3-4 11mm was implanted.Patient's current health status is unknown.
Additional Manufacturer Narrative
H10: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The base of the device is damaged, possibly due to not being seated completely.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 this case reports, after a tka was performed (date unspecified), ¿the patient experienced pain after standing 20 minutes¿ and a subsequent revision.¿reportedly, a pre-revision mri revealed ¿the poly was not fully seated¿ and was possibly ¿damaged at some time¿.Per case details, upon opening the knee, it was found the ¿ps xlpe was not fully locked,¿ and ¿appeared to be fully seated in extension but when we flexed the knee, it was not locked.¿ additionally, per case communication, ¿soft tissues that may have been possible interfering with locking mechanism,¿ were removed during the revision.Reportedly, after 5 failed attempts to lock in the revision poly, the primary tibial baseplate was revised.Two photos of the returned device were reviewed and do not provide insight into the reported problem.The patient¿s current health status is unknown and no additional requested information was provided.Without the requested information, the root cause of the reported events cannot be definitively concluded.The patient impact beyond the reported symptoms, events and revision cannot be determined and the patient¿s current health status remains unknown.Therefore, no further clinical medical assessment can be rendered.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 file and instructions for use document 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 contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.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.Internal complaint reference number: (b)(4).

• Brand Name: GNS II CMT TIB SIZE 3 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: 13636370
• Report Number: 1020279-2022-00942
• Device Sequence Number: 13994091
• Product Code: JWH
• UDI-Device Identifier: 03596010206336
• UDI-Public: 03596010206336
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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 Model Number: 71420182
• Device Catalogue Number: 71420182
• Device Lot Number: 18JM20382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2018
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown