MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,

Model Number	71453201
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case: (b)(4).
Event or Problem Description
It was reported that a revision surgery was performed due to a poly fracture.Poly is broken medially and dislodged.The patient outcome is unknown.No additional information was provided at this time.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.The lab analysis concluded that the as received components were each visually inspected for signs of damage.The femoral component showed bone and bone cement adhesion to all the bone contacting surfaces.Damage was observed on the sides of the articular surface as well as burnishing on the articulating surface of the medial and lateral condyles.This damage was likely due to contact with the tibial baseplate.The tibial insert showed damage to the articulating surface as well as the inferior surface of the insert.The posterior lock was damaged and worn through on the medial side.The damage observed on the posterior lock regions suggests the insert may not have been fully engaged into the shell.No material or manufacturing defects were observed during this investigation.The clinical/medical evaluation concluded that based on the information provided, the clinical root cause of the reported revision was most likely the disassociation or breakage of the articular poly-insert from the tibial baseplate with subsequent medial articulation of the femoral component onto the tibial baseplate; however, the root cause of the disassociated poly could not be definitively concluded.The patient impact beyond the reported events and revision procedure could not be determined.No further medical assessment could be rendered at this time.Although the product evaluation is pending at this time, should the product evaluation reveal pertinent findings and/or additional clinical data becomes available in the future, the clinical/medical task may be re-evaluated.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 1-2 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11221032
• Report Number: 1020279-2021-00540
• Device Sequence Number: 19772002
• Product Code: JWH
• UDI-Device Identifier: 00885556033784
• UDI-Public: 00885556033784
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 71453201
• Device Catalogue Number: 71453201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 01/24/2021
• Supplement Report FDA Received Date: 09/14/2021
• 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; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 108