MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS, STEM EXTENSION, CANAL FILLING, STRAIGHT; PROSTHESIS, STEM

Model Number KSP17100E

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Infection (1930)

Event Date 02/21/2018

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

A revision surgery was performed to drain and irrigate the knee due to an alleged infection.During the revision surgery, it was found that the resurfacing femur had loosened and dissociated from the stem extension.

Event Description

A revision surgery was performed to drain and irrigate the knee due to an alleged infection.During the revision surgery it was found that the resurfacing femur had loosened and the resurfacing femur and stem extension dissociated.

Manufacturer Narrative

This medical device report (mdr) was initiated as part of a retrospective assessment of complaints under onkos surgical capa (b)(4).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 five devices involved in the event, please refer to report 3013450937-2018-00007, 3013450937-2018-00064, 3013450937-2018-00065, and 3013450937-2018-00066 for the others.The device history record, sterilization batch release record, and analysis of returned product indicated that the components involved met specification.The operation notes were provided for review, which confirmed the adverse event.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.

• Brand Name: ELEOS, STEM EXTENSION, CANAL FILLING, STRAIGHT
• Type of Device: PROSTHESIS, STEM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 7350367
• MDR Text Key: 102840872
• Report Number: 3013450937-2018-00006
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278KSP17100E0
• UDI-Public: B278KSP17100E0
• 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: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KSP17100E
• Device Catalogue Number: KSP17100E
• Device Lot Number: 1696594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR