MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PRSFT STEM 10MMX220MM STRT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	71424063
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a right knee revision surgery was performed due to a fractured implant.
Additional Manufacturer Narrative
The 510ks of associated concomitant devices: k081111, k043440.
Additional Manufacturer Narrative
The associated complaint devices were returned.The damage observed on the press fit stem is consistent with implant extraction damage.The fractured ends have been burnished to a smooth surface.This was likely caused by the fractured ends of the stem rubbing prior to extraction.Damage seen on the cement stem, on the tibial baseplate¿s polished and anterior surfaces, and on the post bushing could have been caused during removal.Wear seen on the articular surface of the femoral assembly may have been caused by third body debris or during removal.Wear seen on the hinge sleeve was likely caused by normal use.The amount of cement seen on the fixation surface indicates that there may compromised bone stock.Damage observed on the articular surface of the tibial insert may have been caused by third-body particulate or during the removal.The implant was received with the femoral assembly attached to the tibial baseplate.The tibial baseplate set screws have been cemented in place and can be felt inside of the female taper.No deviations were observed during the lab analysis.The batch number of the fractured press fit stem is unknown.Without the requested medical images, the root cause cannot be concluded.The patient¿s weight, the known distal defects, and thin femoral condyles together with a well fixed proximal femoral stem might have contributed to fracture.The noted quantity of bone cement of the femoral component indicates that it is likely that there was less stability of the component, which could lead to micro motion and stress on the stem.Wear to the fracture surfaces of the stem documented in the lab analysis prohibited the fatigue stress assessment.No further investigation is 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 PRSFT STEM 10MMX220MM STRT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6962078
• Report Number: 1020279-2017-00889
• Device Sequence Number: 13632923
• Product Code: JWH
• UDI-Device Identifier: 03596010546869
• UDI-Public: 03596010546869
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2018

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 Catalogue Number: 71424063
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 10/16/2017; 10/16/2017
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 02/13/2018; 05/02/2018
• 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: 70 YR
• Patient Weight: 160