MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; MALE-FEMALE MIDSECTION, 90MM

Model Number	25001090E
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause of the infection was unable to be determined.The root cause of the metallosis is still under investigation.No manufacturing or sterilization issues were found that would have contributed to this complaint.Raw material dhrs have been requested.An updated report will be submitted when more information is available.
Event or Problem Description
A patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) due to metal debris in the soft tissue envelope.The surgeon removed the implants and washed out the area to remove the metal debris.During the operation, it was determined that the patient also had an infection around the implants.Blood work determined that the chromium levels in the patient's blood were high at approximately 11 gl.Normal blood chromium levels are less than or equal to 1.4 gl.All of the implants were removed except for the femoral stem which was left in place due to the surgeon believing that it would negatively affect the patient's femur if they removed it.The patient will return for surgery to have new implants placed.
Additional Manufacturer Narrative
The implant that was initially reported was beleived to be explanted during the revision surgery that occured on (b)(6) 2021.However, this implant was revised on (b)(6) 2020.This report was updated to have information on the implant that was placed during the previous revision surgery and was explanted on (b)(6) 2021.Below is the updated conclusion.The root cause for failure was not definitively determined.No information is known about the patient's condition nor if they were experiencing symptoms from the metalosis, the infection, or if the implants were damaged to the point that it was affecting their gate or mobility.The patient had also reported hip instability.It is unknown if the eleos implants contributed to this.The patient did not have implants in the area of their hip.It is unknown why the devices were explanted during a separate surgery as when the new implants were placed.The infection may have contributed to this.The implants were discarded after surgery; therefore, they were unavailable for testing.However, review of the manufacturing, the raw material, and sterilization records as well as analysis of previous nonconformances and complaints did not find any issues that occurred during the manufacturing of the implant that would have contributed to this complaint.The raw material dhr for the cobalt chrome utilized for this component was reviewed and found that the material met the required astm material specifications as well as onkos material requirements.This information was not known until the raw material dhrs were obtained form the contract manufacturer on (b)(6) 2021.
Event or Problem Description
A patient underwent a revision surgery on(b)(6) 2021 performed by dr.Mollabashy due to metal debris in the soft tissue envelope.The surgeon removed the implants and washed out the area to remove the metal debris.During the operation, it was determined that the patient also had an infection around the implants.Blood work determined that the chromium levels in the patient's blood were high at approximately 11 [?]g[?]l.Normal blood chromium levels are less than or equal to 1.4 [?]g[?]l.All of the implants were removed except for the femoral stem which was left in place due to the surgeon believing that it would negatively affect the patient's femur if they removed it.The patient returned for a subsequent surgery to have eleos components placed.
Additional Manufacturer Narrative
The raw material dhr for the cobalt chrome utilized for this component was reviewed and found that the material met the required astm material specifications as well as onkos material requirements.This information was not known until the raw material dhrs were obtained form the contract manufacturer on 15 june 2021.
Event or Problem Description
A patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) due to metal debris in the soft tissue envelope.The surgeon removed the implants and washed out the area to remove the metal debris.During the operation, it was determined that the patient also had an infection around the implants.Blood work determined that the chromium levels in the patient's blood were high at approximately 11 [?]g[?]l.Normal blood chromium levels are less than or equal to 1.4 [?]g[?]l.All of the implants were removed except for the femoral stem which was left in place due to the surgeon believing that it would negatively affect the patient's femur if they removed it.The patient will return for surgery to have new implants placed.

• Brand Name: ELEOS
• Common Device Name: MALE-FEMALE MIDSECTION, 90MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11683013
• Report Number: 3013450937-2021-00048
• Device Sequence Number: 2935548
• Product Code: KRO
• UDI-Device Identifier: B27825001060E0
• UDI-Public: B27825001060E0
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup,Followup
• Report Date (Section B): 06/23/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2025
• Device Model Number: 25001090E
• Device Catalogue Number: 25001090E
• Device Lot Number: 1701663
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 03/19/2021; 03/19/2021
• Initial Report FDA Received Date: 04/17/2021
• Supplement Report FDA Received Date: 06/16/2021; 06/23/2021
• 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: 68 YR