MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; SEGMENTAL STEM , CANAL-FILLING, STRAIGHT, SPLINED, PLASMA, 28MM COLLAR, 11X120MM

Model Number	FS-11120-03M
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the stem loosening was unable to be definitively determined.The sales representative stated that the surgeon reamed the patient's femur about one half of a millimeter larger than is recommended in the surgical technique.It is possible that this led to the loosening of the implant.The manufacturing and sterilization records were reviewed and found no nonconformances or other issues that would have contributed to this complaint.
Event or Problem Description
A patient underwent a revision surgery on (b)(6) 2021 performed by doctor.(b)(6) due to a femoral canal-filling segmental stem loosening.The segmental stem was placed during the patient's primary eleos surgery which was also performed by (b)(6).The sales representative reported that the surgeon was having trouble placing the stem, so he reamed the patient's femur one half of a millimeter more than was recommended by the surgical technique.The sales representative, (b)(6), stated that he advised the surgeon of this, but the surgeon still reamed the femur more that was recommended.Prior to the revision surgery, the patient was found to have his femoral stem loosening and a revision surgery was performed.During the revision, the canal-filling stem as explanted and a cemented stem with he same dimensions of 11x120mm was placed.The loosening was aseptic, and no infection was found.

• Brand Name: ELEOS
• Common Device Name: SEGMENTAL STEM , CANAL-FILLING, STRAIGHT, SPLINED, PLASMA, 28MM COLLAR, 11X120MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11693838
• Report Number: 3013450937-2021-00050
• Device Sequence Number: 3610677
• Product Code: KRO
• UDI-Device Identifier: B278FS1112003M0
• UDI-Public: B278FS1112003M0
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2021

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: 01/18/2024
• Device Model Number: FS-11120-03M
• Device Catalogue Number: FS-11120-03M
• Device Lot Number: 81691
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/20/2021
• 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: 42 YR