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

Model Number	71420170
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Laceration(s) (1946); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tkjr surgery had been performed on (b)(6) 2012, the patient reported an unknown problem.The adverse event was addressed with a revision surgery on (b)(6) 2021 to replace the tibial baseplate, femoral component and the insert.Additionally was observed that there was no cement on the back of the implant, indicating that the product had failed had the cement/implant interface.The condition of the patient is unknown.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after a tkjr surgery had been performed on (b)(6) 2012, the patient reported suffering from major knee effusion, lysis, poor rom and pain.The adverse event was addressed with a revision surgery on (b)(6) 2021 to replace the tibial baseplate, femoral component and the insert.Additionally was observed that there was no cement on the back of the implant, indicating that the product had failed had the cement/implant interface.The patient is on early stage of recovery.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, the reported ¿major knee effusion, lysis, poor rom and pain¿ may be consistent with the reported failure of the cement/implant interface; however, with the limited information provided the clinical root cause of the reported clinical reactions/ events cannot be confirmed.It cannot be concluded that the reported events/clinical reactions were associated with a mal performance of the implant or implant failure.A review of the manufacturing records 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 risk management file and instructions for use documents 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 product specifications at the time of manufacture.Some potential probable causes could be alignment, fit/size of device used, failure of the cement/implant interface, surgical complications, traumatic injury or wear.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 13022487
• Report Number: 1020279-2021-08709
• Device Sequence Number: 14696675
• Product Code: JWH
• UDI-Device Identifier: 03596010206282
• UDI-Public: 03596010206282
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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 Expiration Date: 04/23/2022
• Device Model Number: 71420170
• Device Catalogue Number: 71420170
• Device Lot Number: 12DT17924
• 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: 11/29/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2012
• 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