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	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during tka surgery, there was a gap between the gnsii con ins sz3-4 11mm and the baseplate.The procedure could not be completed.No injury to patient or significant delay 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 has signs of damage from attempted use.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.The clinical medical investigation concluded that per the complaint details, we currently are unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.After three requests no relevant clinical information, operative reports, or radiograph were provided.Based on the information provided, due to a gap between the insert and the baseplate, the surgeon used a smith and nephew back up device to complete the procedure.Since there was no injury to patient or significant delay reported, no further clinical/medical assessment is warranted at this time.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.A review of risk management files and instructions for use found that the reported failure was documented appropriately.At this time, we have no 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: 11977676
• Report Number: 1020279-2021-05113
• Device Sequence Number: 14300034
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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: 71420524
• Device Catalogue Number: 71420524
• Device Lot Number: D1923147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 08/24/2021
• 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
• Patient Weight: 75