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

Model Number	71420166
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that after a tka procedure had been finished, the customer noticed that the labels did not match when reordering the op consumption.According to the inside label (sticker), a gns ii cmt tib size 4 left has been installed.The customer said the outside label said journey tibial component.The outer packaging is no longer available.It is unclear which component was actually implanted.Patient was not harmed.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the device was not returned for evaluation.The pictures provided were reviewed and according to the clinical team the specific device type cannot be determined from the radiologic imaging.The clinical/medical investigation concluded that, based on a review of the information provided, the root cause of the reported implant labeling discrepancy cannot be definitively concluded, however the customer¿s documentation/inventory process cannot be ruled out as a contributing factor to the reported events.A recommended best practice standard is to confirm the shipped component matches the inner and outer container labeling and the chartstiks/stickers prior to implantation.Additionally, it cannot be concluded that the labels not matching is due to the incorrect packaging of the implants.Per the findings from the phr device labeling/ifu review, ¿according to the production order, a review of the outer and inner labels was conducted and both labels had the correct information on them.The device is a gns ii cmt tib size 4 left.¿ per case details, it was communicated that journey ii bcs cocr size 6 and a journey ii bsc xlpe inserts were also implanted.The instructions for use for smith and nephew knee systems instructs: each total knee system is designed as a system and does not allow the substitution of components from other systems or manufacturers.All implantable devices are designed for single use only.Because its unknown if the correct tibial baseplate was implanted, the impact cannot be concluded, and the patient impact beyond the reported cannot be determined.However, it was reported ¿the patient was not harmed.¿ therefore, no further clinical/medical assessment is warranted.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident, additionally a review of the outer and inner labels was conducted and both labels had the correct information on them.The gns ii cmt tib size 4 left device was manufactured at the aarau site of smith and nephew.However, journey ii tibial baseplate devices are not manufactured in aarau.Furthermore, the parts of this gns ii cmt tib size 4 left batch went from aarau directly via arvato gdc (nl) to marl (ger), so a potential repackaging issue can be excluded.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include user error and/or mishandling.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.Internal complaint reference number: (b)(4).

• Brand Name: GNS II CMT TIB 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
• 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: 15393572
• Report Number: 1020279-2022-04042
• Device Sequence Number: 6463823
• Product Code: JWH
• UDI-Device Identifier: 03596010206268
• UDI-Public: 03596010206268
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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: 71420166
• Device Catalogue Number: 71420166
• Device Lot Number: G2134932
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female