MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER 4MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71424225
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to knee instability.During surgery it was discovered that the coupler at the femur side was broken off.
Additional Manufacturer Narrative
Results of investigation: it was reported that a revision surgery was performed due to knee instability.During surgery it was discovered that the coupler at the femur side was broken off.The affected legion offset coupler along with the stem, tibial baseplate, sleeve, bolt, insert, link and femoral component, used in treatment, were returned and evaluated.A lab analysis conducted during this investigation noted that femoral component and tibial baseplate still have bone cement adhered to them.The link assembly is still connected to the condyles of the femoral component.The offset coupler is fractured and a piece of it is still attached to the post of the femoral component.The proximal surface and edges of the tibial baseplate are worn with scratches.The insert has scratches on both the distal and proximal surfaces with the locking screw still attached.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the adverse event could not be corroborated.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.No medical documents were received for investigation.Thus no medical assessment can be performed at this time.Possible causes could include but are not limited to overuse or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: LGN OFFSET COUPLER 4MM
• 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: 9070333
• Report Number: 1020279-2019-03385
• Device Sequence Number: 3762580
• Product Code: JWH
• UDI-Device Identifier: 03596010547132
• UDI-Public: 03596010547132
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K043440
• 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
• Report Date (Section B): 08/20/2020

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: 71424225
• Device Catalogue Number: 71424225
• Device Lot Number: 17ESM0218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71421307 LEGION TIBIAL BASE, LOT: 16MAF0006; 71421632, LEGION LINK ASSEMBLY, LOT:16KAF0009; 71421681 LEGION 11MM SLEEVE, LOT:17JTM0027; 71421686, LEGION 11MM BOLT, LOT: 17LTM0001; 71423363, LEGION INSERT, LOT:17EM15664; 71424192, LEGION STEM (MM), LOT: 10JAP0374
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention