MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II C/R FEM SIZE 4 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420006
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant could not be removed from the packaging because the implant was fused to the packaging.This was noticed directly when opening the packaging.No surgery time delay.Implant was not in the patient.S&n back up device available to complete the procedure.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was returned opened with its original packaging except for the outer box.The inner protective liners were slightly deformed.One edge of the inner tyvek lid appeared to be captured within the outer tyvek lid.The device was manufactured in 2020 and shows no signs of use.The packaging development evaluation concluded that an inner tray with snap lid, tyvek lid, pu tray liner, pu snap lid, and femoral was visually inspected.The complaint stated the femoral was fused to the inner packaging.They were not able to confirm the stated complaint.They inspected the femoral and did not see any of the pu liner on the femoral.They were also able to remove the femoral from the package with ease.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.Improper storage is a potential probable cause for this event.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.
Additional Manufacturer Narrative
The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was returned opened with its original packaging except for the outer box.The inner protective liners were slightly deformed.One edge of the inner tyvek lid appeared to be captured within the outer tyvek lid.The device was manufactured in 2020 and shows no signs of use.The packaging development evaluation concluded that an inner tray with snap lid, tyvek lid, pu tray liner, pu snap lid, and femoral was visually inspected.The complaint stated the femoral was fused to the inner packaging.They were not able to confirm the stated complaint.They inspected the femoral and did not see any of the pu liner on the femoral.They were also able to remove the femoral from the package with ease.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.Improper storage is a potential probable cause for this event.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.
Event or Problem Description
It was reported that the implant could not be removed from the packaging because it was fused to the packaging.This was noticed directly when opening the packaging.No surgery time delay.Implant was not used and a s+n back up device was available to complete the procedure without patient impact.This event was conservatively reported since complications during treatment have been reported in the past for this failure mode, such as use of an alternative device to complete the procedure, but no patient harm has been reported.This alternative treatment is considered medical or surgical intervention to preclude permanent damage to a body structure or body function.
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 could not confirm the stated failure mode.The device was returned opened with its original packaging except for the outer box.The inner protective liners were slightly deformed.One edge of the inner tyvek lid appeared to be captured within the outer tyvek lid.The device was manufactured in 2020 and shows no signs of use.The packaging development evaluation could not confirm the stated failure mode that the femoral was fused to the inner packaging.They inspected the femoral and did not see any of the pu liner on the femoral.They were also able to remove the femoral from the package with ease.There is no evidence of the femoral fusing to the liner.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.Improper storage is a potential probable cause for this event.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 C/R FEM SIZE 4 LEFT
• 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: 10355609
• Report Number: 1020279-2020-03632
• Device Sequence Number: 14053196
• Product Code: JWH
• UDI-Device Identifier: 03596010205445
• UDI-Public: 03596010205445
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/04/2020

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: 71420006
• Device Catalogue Number: 71420006
• Device Lot Number: 20AM26545
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 09/23/2020; 09/23/2020; 10/15/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 09/24/2020; 09/25/2020; 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1