MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CM TIB SIZE 2 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420180
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2019, the patient was revised on (b)(6) 2021 because the locking mechanism of the tibial baseplate was not working and the poly was not locking.This was the second revision surgery performed to this patient, the first revision was performed on (b)(6) 2021 for poly breakage ((b)(4)).No surgical delay was reported.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection was completed on the tibial baseplate.Cement is on the backside of the plate but there is no bone growth that can be visually seen.There are scratches on the lock detail, that could be caused from removing the implant.The clinical/medical evaluation concluded that based on the limited information provided, the clinical root cause of the reported event could not be definitively concluded; however, per the visual product inspection, there was ¿no bone growth that can be visually seen¿ on the backside of the baseplate and ¿scratches on the lock detail¿ were noted.The scratches on the lock detail cannot be ruled out as a potential contributing factor to the reported event.It also cannot be concluded that the retained tibial baseplate during the first revision was in optimal working condition after the suspected contact with the femoral component for which the first revision was performed.The assessed patient impact was the reported poly not locking and revision of tibial component with an anticipated transient post-operative rehabilitation phase.Further patient impact could not be concluded.Should additional clinical data become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.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 documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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.

• Brand Name: GII CM TIB SIZE 2 RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12111910
• Report Number: 1020279-2021-05634
• Device Sequence Number: 11706087
• Product Code: JWH
• UDI-Device Identifier: 03596010206329
• UDI-Public: 03596010206329
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 71420180
• Device Catalogue Number: 71420180
• Device Lot Number: 18CM02953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKN GENESIS II TOTAL KNEE TIB INSERT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR