MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK HYPEREXT STOP W/AX PLUG; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR

Catalog Number	71421648
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due ti lateral poly plug had become dislodged and hinge axle was protruding laterally.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis during this investigation noted that abrasion, burnishing and deformation were observed in the bearing regions on the superior surface of the tibial insert, the inferior surface of the insert displayed a lower level of abrasion, burnishing and deformation.The immediate cause of the dislodged poly plug and hinge axle could not be determined.No material or manufacturing deviations were observed in this investigation.A clinical investigation concluded based on the information available, the root cause for the breakage of the poly-plug and the migration of the hinge axle cannot be determined as the rest of the hinge components remained implanted and only the revised portions from the rebuild were available for evaluation.There was no report of a fall or trauma that precipitated this event.It is unknown, if this patient¿s ¿dense arthrofibrosis throughout the joint or the patient¿s body habitus with a bmi of 39.5 played a role in this event.No information on the patient¿s current status has been submitted at this time.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.A review of complaint history on the listed parts revealed no additional complaints for this failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.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.Should additional information be received, the complaint will be reopened.

• Brand Name: LGN HK HYPEREXT STOP W/AX PLUG
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7375042
• Report Number: 1020279-2018-00612
• Device Sequence Number: 1067961
• Product Code: JWH
• UDI-Device Identifier: 00885556030509
• UDI-Public: 00885556030509
• Combination Product (Y/N): N
• 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): 05/28/2018

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: 71421648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 05/28/2018
• 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: 62 YR