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

Model Number	KSP17100E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, STEM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 7350367
• Report Number: 3013450937-2018-00006
• Device Sequence Number: 19028785
• Product Code: KRO
• UDI-Device Identifier: B278KSP17100E0
• UDI-Public: B278KSP17100E0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

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 Expiration Date: 03/20/2025
• 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
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 09/12/2018
• 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: Required Intervention
• Patient Age: 46 YR