MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; ELEOS STEM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Infection (1930)

Event Date 06/13/2022

Event Type  Injury  

Event Description

It was reported that a patient experienced loosening of their implanted eleos stem.The patient was scheduled to be revised due to the loosened stem; however, it was discovered that the patient had an active infection.The revision procedure was cancelled due to the discovery of the infection.Additional information regarding the device and event is unknown at this time.This event will be reported to the fda as a serious injury due to the scheduled revision procedure.This record captures the eleos stem.

Event Description

It was reported that a patient experienced loosening of their implanted eleos stem.The patient was scheduled to be revised due to the loosened stem; however, it was discovered that the patient had an active infection.The revision procedure was cancelled due to the discovery of the infection.Additional information regarding the device and event is unknown at this time.If additional information regarding this case becomes available, a supplemental will be submitted.This event will be reported to the fda as a serious injury due to the scheduled revision procedure.This record captures the eleos stem.

Manufacturer Narrative

It was reported that a patient was scheduled to be revised on (b)(6) 2022 due to loosening of an eleos stem.However, this surgery was cancelled as the patient had an active infection.A revision surgery has not been scheduled at this time.The product information for the implant involved in this complaint is unknown.Therefore, the work order and sterilization batch release record, for the implant involved in this complaint could not be reviewed.Visual, dimensional, functional inspection and material analysis could not be conducted as the device was not returned for evaluation.Additional information regarding this case is unknown.If additional information is received, this submission will be updated accordingly.

• Brand Name: ELEOS
• Type of Device: ELEOS STEM
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 15005506
• MDR Text Key: 295861703
• Report Number: 3013450937-2022-00200
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention