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

Device Problems Positioning Failure (1158); Dent in Material (2526)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event 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 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 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.

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
• Type of Device: 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
• MDR Text Key: 313824149
• Report Number: 1020279-2023-00885
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010208187
• UDI-Public: 03596010208187
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K951987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 04/12/2023; 05/16/2023
• Supplement Dates FDA Received: 04/21/2023; 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 150 KG