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

Model Number	SPSE0004E
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SEGMENTAL STEM, 16MM X152MM, STRAIGHT, SLOTTED, SPLINED, 2/3 PLASMA, 25MM COLLAR
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 10663404
• Report Number: 3013450937-2020-00147
• Device Sequence Number: 2990861
• Product Code: KRO
• UDI-Device Identifier: B278SPSE0004E0
• UDI-Public: B278SPSE0004E0
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2025
• Device Model Number: SPSE0004E
• Device Catalogue Number: SPSE0004E
• Device Lot Number: 1701341
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2020
• 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: 63 YR