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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after tka a revision surgery was performed due to unknown reasons, the gen ii ps (case (b)(4)), gen ii baseplate (case (b)(4)) and ps insert (case-(b)(4)) were explanted.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A medical investigation was conducted and confirms per subsequent e-mail, no consent has been granted for patient details and medical history.In addition, the attached pc form has been reviewed; however, it does not aid in determining the root cause for the reported revision.Since it was reported all three of the devices were explanted and no other complications were reported, no further clinical/medical 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.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.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, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11016056
• Report Number: 1020279-2020-07475
• Device Sequence Number: 4260198
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2023
• Device Model Number: 71420170
• Device Catalogue Number: 71420170
• Device Lot Number: 13HT34187
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention