MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; SEGMENTAL STEM, 16MM X152MM, STRAIGHT, SLOTTED, SPLINED, 2/3 PLASMA, 25MM COLLAR

Model Number SPSE0004E

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

The root cause for the incorrect selection of the component was unable to be determined.Most likely, the cause was human error in selecting the size that was needed for the patient, the component was appropriately sized.Based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture of the implants or a nonconformance.

Event Description

A (b)(6) male patient underwent a revision surgery on (b)(6) 2020 performed by dr.(b)(6) due to dissociation of the resurfacing femur component and femoral stem extension component.During the revision, a canal-filling segmental stem was press fit into the bone but it did not purchase into the bone and it was determined that it was too small of a diameter.The surgeon explanted stem and selected a larger diameter stem which was then implanted.

• Brand Name: ELEOS
• Type of Device: SEGMENTAL STEM, 16MM X152MM, STRAIGHT, SLOTTED, SPLINED, 2/3 PLASMA, 25MM COLLAR
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: jonathan zachok ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 10663404
• MDR Text Key: 211017258
• Report Number: 3013450937-2020-00147
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278SPSE0004E0
• UDI-Public: B278SPSE0004E0
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPSE0004E
• Device Catalogue Number: SPSE0004E
• Device Lot Number: 1701341
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 63 YR