MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PRESSFIT STEM 16MM X 160MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number 71424049

Device Problem Separation Problem (4043)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2021

Event Type  Injury  

Event Description

It was reported that, a left knee revision surgery was performed and the lgn hk dis fem wdg sz3 5mm has separated from the lgn pressfit stem.Screws were not used upon impaction of femoral stem per surgeon¿s request.It is unknown whether the primary surgery was performed with smith-nephew devices or the cause of the current revision surgery.Patient outcome is unknown.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation but the images provided were reviewed, and the separation was confirmed.The clinical/medical investigation concluded that, reportedly, reportedly, the root cause of the revision was separation of the wedge/femoral component from the press-fit stem.The provided imaging appears to support the complaint.The surgical technique supports the use of correct alignment, impact force and screws.The set screws, however, were reportedly not used during impaction, and therefore, was most likely the contributing factor to the reported event.The patient impact beyond the reported revision procedure and an expected post-operative rehabilitation phase could not be determined.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as procedural variance, abnormal motion over time, bone degeneration, lack of ingrowth and/or traumatic injury.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 the device or 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.

• Brand Name: LGN PRESSFIT STEM 16MM X 160MM
• Type of Device: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11722106
• MDR Text Key: 247221156
• Report Number: 1020279-2021-03411
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010546814
• UDI-Public: 03596010546814
• Combination Product (y/n): N
• PMA/PMN Number: K072531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71424049
• Device Catalogue Number: 71424049
• Device Lot Number: 19HSM0491
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71421303, LOT: 18GBP0016; 71421388, LOT: 19HTM0041A; 71421389, LOT: 19FTM0026; 71422153, LOT: 13MAP1406G; 71423347, LOT: 18GM17392; 71423349, LOT: 17JM20486; 71424029, LOT: 19FSM0574; 71424223, LOT: 19MSM0139; 71935387, LOT:20DTX0017; 75100524, LOT: A73355; 75100526, LOT: A73049
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 73 YR