MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK DIS FEM WDG SZ3 5MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71421373
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
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, 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 HK DIS FEM WDG SZ3 5MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11722111
• Report Number: 1020279-2021-03415
• Device Sequence Number: 17085022
• Product Code: KRO
• UDI-Device Identifier: 00885556414910
• UDI-Public: 00885556414910
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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: 71421373
• Device Catalogue Number: 71422153
• Device Lot Number: 20AM18524
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 04/25/2021
• Supplement Report FDA Received Date: 08/23/2021
• 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; Other; Required Intervention