MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS SEGMENTAL STEM CEMENTED; PROSTHESIS, KNEE

Model Number 25004011E

Device Problems Loose or Intermittent Connection (1371); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Swelling (2091)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

The device history record indicated that the released components met all specifications.The complaint history review indicated no trends among components by failure modes.Should additional information be obtained to further this investigation, the report will be updated.

Event Description

The patient presented with a lump on their knee, which was suspected to be caused by an infection.A revision surgery was performed to drain and irrigate the knee.Upon removing the poly components, the surgeon observed that the cemented stem was loose.The surgeon washed the femoral intramedullary canal and placed new components without cement.

Manufacturer Narrative

This medical device report (mdr) was initiated as part of a retrospective assessment of complaints under onkos surgical capa 18-007.As part of this assessment, onkos surgical re-evaluated all complaints received to ensure mdrs were filed when required.The results of this retrospective assessment prompted onkos surgical to file this report.This report is for one of six devices involved in the event, please refer to report 3013450937-2018-00058, 3013450937-2018-00059, 3013450937-2018-00060, 3013450937-2018-00061, and 3013450937-2018-00062 for the others.The device history records and sterilization batch release records were reviewed and indicated that all components involved met specification.The operation notes and explanted components were requested, but it was relayed that they were unable to be obtained.From the available information it was determined that the adverse event was not related to the manufacture of the implants or a non-conformance and this complaint has been closed.Should additional information be obtained the report will be supplemented.

Event Description

The patient presented with a lump on their knee, which was suspected to be caused by an infection.A revision surgery was performed to drain and irrigate the knee.Upon removing the poly components, the surgeon observed that the cemented stem was loose.The surgeon washed the femoral intramedullary canal and placed new components without cement.

• Brand Name: ELEOS SEGMENTAL STEM CEMENTED
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 7307843
• MDR Text Key: 101344708
• Report Number: 3013450937-2018-00003
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825004011E0
• UDI-Public: B27825004011E0
• Combination Product (y/n): N
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25004011E
• Device Catalogue Number: 25004011E
• Device Lot Number: 1699500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR