MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL POLY SPACER, 20MM

Model Number	25001220E
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The problem that occured with the device is unknown and will be provided when available with a follow up report.However, the manufacturing records and sterilization documents were reviewed and no issues were identified during manufacturing.No nonconformaces were identified that would have contributed to the complaint.
Event or Problem Description
A (b)(6) female underwent a revision surgery on (b)(6) 2020 performed by dr.(b)(6).The details of the event are unknown at this time.The sales representative has not responded to inquiries regarding this incident.A follow up report will be submitted when more information is known.
Additional Manufacturer Narrative
An initial report was submitted due to the sales representative not communicating with onkos surgical.On (b)(6) 2020, the sales representative reported that the patient had experienced a dissociation of the distal femur component and a male-female midsection.After investigation, the root cause for the dissociation of the resurfacing femur and the male-female midsection was unable to be determined.The patient's medical history is unknown, and it is unknown whether the patient sustained a trauma prior to the failure.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.The sales representative also stated that the implants were implanted on (b)(6) 2020 rather than (b)(6) 2020 which was initially reported.
Event or Problem Description
A 69- year old female underwent a revision surgery on (b)(6) 2020 performed by (b)(6) due to dissociation of the distal femur component and a male-female midsection.The male-female midsection was not implanted at the time of the revision surgery and the new distal femur component was impacted into it.

• Brand Name: ELEOS
• Common Device Name: TIBIAL POLY SPACER, 20MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 10525124
• Report Number: 3013450937-2020-00122
• Device Sequence Number: 1270049
• Product Code: KRO
• UDI-Device Identifier: B27825001220E0
• UDI-Public: B27825001220E0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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: 11/14/2017
• Device Model Number: 25001220E
• Device Catalogue Number: 25001220E
• Device Lot Number: 1714462
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/07/2020
• 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: 69 YR