MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 11; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number 71421509

Device Problem Misassembled (1398)

Patient Problem Injury (2348)

Event Date 01/14/2019

Event Type  Injury  

Event Description

A revision surgery was performed due to the poly came out of the tibia causing metal wear.

Manufacturer Narrative

The associated complaint devices were returned for evaluation.Our lab analysis confirms all three knee components were investigated and had damage present.Burnishing and scratches were present on the articulating surface of the femoral component.The sides of the articulating surface also had scratches present.The bone contacting surface of the femoral component had bone cement still adhered to it.The insert was worn with scratches on the articulating and non-articulating surfaces, as well as the sides and post.The locking detail on the insert was deformed with debris present.The tibial baseplate was damaged on the proximal surface with scratches, burnishing, and apparent wear.The locking detail on the baseplate was also burnished and deformed.The bone contacting surface of the baseplate had bone cement still adhered to it.There were no observations of material or manufacturing deviations in the course of this investigation.These devices were manufactured in 2017 and 2018.A clinical evaluation was conducted and there were no observations of material or manufacturing deviations during the product investigation.Based on the limited information provided the root cause of the reported poly insert dissociation from the tibial baseplate cannot be determined.However the reported metal wear is likely due to the dislodgment of the poly insert.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII PS HI FLEX ISRT SZ 3-4 11
• Type of Device: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8305927
• MDR Text Key: 135030958
• Report Number: 1020279-2019-00435
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010492364
• UDI-Public: 03596010492364
• Combination Product (y/n): N
• PMA/PMN Number: K032295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71421509
• Device Lot Number: 17MM03427
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention