MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CON INS SZ7-8 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420552
Medical Device Problem Codes	Positioning Failure (1158); Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a tka surgery, one (1) gns ii con ins sz7-8 11mm could not be "clicked" into place.Several attempts were necessary, but without success.The gns ii con ins sz7-8 11mm had a dent on the back.The procedure was resumed, after a non significant delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
Event or Problem Description
It was reported that, during a tka surgery, one (1) gns ii con ins sz7-8 11mm could not be "clicked" into place.Several attempts were necessary, but without success.The gns ii con ins sz7-8 11mm had a dent on the back.The procedure was resumed, after a non significant delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
Event or Problem Description
It was reported that, during a tka surgery, one (1) gns ii con ins sz7-8 11mm could not be "clicked" into place.Several attempts were necessary, but without success.A dent on the device was detected after the unsuccessful insertion attempts, which was likely created from the excessive intraoperative manipulation.The procedure was resumed, after a non significant delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H11: this complaint has been reassessed based on additional information gathered by the manufacturer.It was determined that this event does not fulfill reporting requirements per 21 cfr §803 regulations.The insert positioning problem did not lead to death or serious injury.It has been communicated that the procedure was able to be completed using a back up insert without a significant surgical delay.In addition, the reported dent in the material was likely created as a consequence of the unsuccessful insertion attempts and not due to a manufacturing issue.

• Brand Name: GNS II CON INS SZ7-8 11MM
• 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: 16781891
• Report Number: 1020279-2023-00885
• Device Sequence Number: 6378128
• Product Code: JWH
• UDI-Device Identifier: 03596010208187
• UDI-Public: 03596010208187
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71420552
• Device Catalogue Number: 71420552
• Device Lot Number: D1820293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 04/12/2023; 05/16/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 04/21/2023; 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2018
• 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
• Patient Sex: Male
• Patient Weight: 150 KG