MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNSII CON INS SZ3-4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420524
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during gii knee surgery, the insert and the tibial baseplate did not fit together and there was a gap in the middle, making the product unusable.Finally, a s+n backup of the insert was used to complete the surgery.A delay of 30 min or less was reported.No patient harm was reported.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device shows damage on the lock detail probably from the attempted insertion.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing or product specifications did not reveal abnormalities that could have contributed to the reported issue.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GNSII CON INS SZ3-4 11MM
• 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: 11169240
• Report Number: 1020279-2021-00401
• Device Sequence Number: 19827727
• Product Code: JWH
• UDI-Device Identifier: 03596010208040
• UDI-Public: 03596010208040
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/28/2021

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: 71420524
• Device Catalogue Number: 71420524
• Device Lot Number: 20AT32483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1