MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 6 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY

Model Number	71420170
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during set up or inspection, after checking the lid of the package, it was found to have a hole in it.The surgeon decided not to keep the implant.It is unknown how the procedure was finished and if there was a surgical delay.No other complications where reported.
Additional Manufacturer Narrative
Results of investigation: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The outer tray lid of the device has a small hole in the corner and the tray is also damaged.The outer box was not returned for evaluation.The device was manufactured in 2020.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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.The potential probable cause for this event is likely improper handling or storage.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: GNS II CMT TIB SIZE 6 LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11229599
• Report Number: 1020279-2021-00587
• Device Sequence Number: 3571026
• Product Code: JWH
• UDI-Device Identifier: 03596010206282
• UDI-Public: 03596010206282
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/07/2021

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: 71420170
• Device Catalogue Number: 71420170
• Device Lot Number: H2014627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1