MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II CEMENTED TIBIAL B/PLATE SZ7 RIGHT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR

Catalog Number	71420190
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed and the doctor noticed that the implants being removed were not adhering to the adhesive on the tibial base.Cement adhesion was present on the femoral components but not on the tibial.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis indicated that minor scratches are visible on the femoral component, and burnishing is seen on the articulating surface of the insert.This was likely caused by femoral component articulation.The locking mechanism on the insert and on the baseplate has minor damage, likely due to removal.The locking mechanism on the baseplate is worn on the edges.Bone cement is still adhered to the femoral component, but the baseplate only has a small amount.There were no observations of material or manufacturing deviations in the course of this investigation.A clinical analysis indicated that based on the available information and the product analysis; there was a "small amount of cement on the baseplate [stem]." and there were no manufacturing deviations reported.It is unknown and cannot be concluded if non-adhesion occurred and contributed to the need for revision surgery but according to the product analysis the lack of adhesion was not linked to the tibial base plate.Also not provided were the details on the cement placement or manufacture of the cement as the timing and procedure of mixing and placement of the cement can have an effect on the adhesion to the implant components as well.Follow-up information on the patient has not been provided.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The complaint history revealed no prior complaints for the listed batches.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GEN II CEMENTED TIBIAL B/PLATE SZ7 RIGHT
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7462732
• Report Number: 1020279-2018-00816
• Device Sequence Number: 1252554
• Product Code: JWH
• UDI-Device Identifier: 03596010206060
• UDI-Public: 03596010206060
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71420190
• Device Lot Number: 13CT29552
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 04/09/2018; 04/09/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 08/09/2018; 09/04/2018
• 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: Hospitalization; Required Intervention