MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN REV TIBIA BASE SZ 3 LT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71424003
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.All parts were removed and replaced with cement moulds from heraeus.No more information available.
Additional Manufacturer Narrative
Additional information: d4 and h4.It was reported that a revision surgery was performed due to infection.All parts were removed and replaced with cement moulds from heraeus.The affected legion oxinium constrained femoral component, legion offset coupler, legion pressfit stem, legion screw distal femoral wedge, legion tibial baseplate and genesis ii constrained insert were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.The devices were sterilized according to sterilization release documentation from quality control.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Infection, a potential complication associated with any surgery, can occur and potential causes could include but not limited to contamination, patient reaction, and post-operative healing issue.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual products involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to infection.All parts were removed and replaced with cement moulds from heraeus.The affected legion oxinium constrained femoral component, legion offset coupler, legion pressfit stem, legion screw distal femoral wedge, legion tibial baseplate and genesis ii constrained insert, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.The devices were sterilized according to sterilization release documentation from quality control.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Infection, a potential complication associated with any surgery, can occur and potential causes could include but not limited to contamination, patient reaction, and post-operative healing issue.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual products involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LGN REV TIBIA BASE SZ 3 LT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9073093
• Report Number: 1020279-2019-03396
• Device Sequence Number: 19600341
• Product Code: JWH
• UDI-Device Identifier: 03596010546074
• UDI-Public: 03596010546074
• Combination Product (Y/N): N
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2020

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 Model Number: 71424003
• Device Catalogue Number: 71424003
• Device Lot Number: 18BM06411
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 08/20/2019; 08/20/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 01/16/2020; 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1