MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; ELEOS 140MM MALE FEMALE MIDSECTION

Lot Number 1885119

Device Problems Delivered as Unsterile Product (1421); Shipping Damage or Problem (1570); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Failure of Implant (1924)

Event Date 08/23/2023

Event Type  malfunction  

Event Description

During distal femur replacement surgery, it was noticed that the inner container of the implant was cracked and deemed unsterile; the product was not used and was returned to onkos; in place of the 140mm midsection, a 90mm and 50mm was used.This resulted in increase # of implants, revision statistics, increase cost to customer.

Manufacturer Narrative

The investigation in progress, additional information for this event is not known at this time, if additional information is received, a supplemental report will be submitted accordingly.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Type of Device: ELEOS 140MM MALE FEMALE MIDSECTION
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsipanny NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 east halsey road; parsipanny NJ 07054
• Manufacturer Contact: vandita patel ; 77 east halsey road; parsipanny, NJ 07054
• MDR Report Key: 18323279
• MDR Text Key: 330431690
• Report Number: 3013450937-2023-00307
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161520
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1885119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2021
• 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
• Treatment: ELEOS MALE-FEMALE MIDSECTION, SIZE 140MM
• Patient Age: 70 YR
• Patient Sex: Female