MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; CANAL FILLING SEGMENTAL STEM

Lot Number	86820
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by (b)(6), an onkos sales representative, that a 61-year-old female patient with an eleos distal femur replacement underwent a revision surgery due to aseptic loosening of an eleos 19x120mm canal filling segmental stem.
Additional Manufacturer Narrative
It was reported by t.Catalano, an onkos sales representative, that a 61-year-old female patient with an eleos distal femur replacement underwent a revision surgery due to aseptic loosening of an eleos 19x120mm canal filling segmental stem.All inspection and manufacturing data was reviewed for the revised eleos implants; all reviewed information was found to be conforming to specifications and no manufacturing abnormalities were observed.As detailed in section 3.5, the ifu and surgical technique documentation identifies elements such as patient contraindications, patient selection factors, surgical procedures/techniques and other precautions/conditions that potentially contribute to adverse effects.The root cause of this complaint was not determined.Based on the review of device history records, the investigation concluded that the root cause of loosening in the canal filling segmental stem was not related to the design, manufacture, and/or sterilization of the previously implanted eleos device.The patient reportedly has poor bone quality which is likely to be a contributing factor to this adverse event.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: CANAL FILLING SEGMENTAL STEM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: yara neurauter ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 18905424
• Report Number: 3013450937-2024-00069
• Device Sequence Number: 9136200
• Product Code: KRO
• UDI-Device Identifier: B278FS1912003M0
• UDI-Public: B278FS1912003M0
• Combination Product (Y/N): N
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2024

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 Lot Number: 86820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CANAL FILLING SEGMENTAL STEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female