MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; SEGMENTAL STEM, CEMENTED, 17X120MM, STRAIGHT, FLUTED

Model Number CS-17120-03M

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

A sales representative stated that a patient sustained a hip dislocation and subsequently underwent a reviison surgery.This was reported to be the second time the patient sustained a hip dislocation and underwent a revision surgery.There was no other information available at this time.The sales representative is gathering information.This report will be supplemented when more information is available.

Event Description

An unknown patient sustained a hip dislocation and underwent a revision surgery.The sales representative stated that this patient had sustained a previous hip discloation.That event was reported in 3013450937-2021-00038.No further information is known at this time.

Manufacturer Narrative

Additional information was provided for this failure.The root cause for the patient's hip dislocating was unable to be definitively determined.The patient's medical history is not known, and it is not known whether the patient sustained a trauma which led to the failure.The revising surgeon removed a femoral head with a +7mm taper and added a femoral head with +10.5mm of taper.This was done in an attempt to mitigate the risk of further dislocations.The patient had already dislocated their hip which led to a previous revision surgery.However, the manufacturing dhrs and sterilization records, as well as complaint and ncr history, were reviewed and no issues were found that would have contributed to this complaint.Additional mdrs for this complaint were submitted via the following reports: 3013450937-2021-0039 follow up #001.

Event Description

This report investigated a revision surgery of eleos components for a patient's whose hip dislocated twice after eleos implants were placed.Both times, eleos components were revised.This report will focus on the second revision surgery which was a result of the second instance of this patient's hip dislocating which occurred on (b)(6) 2021.This patient also underwent a previous revision surgery on (b)(6) 2021 due to their hip dislocating again.Both of these failures were not reported until 16 march 2021.A patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) after a patient's hip dislocating.This was the second time the patient's hip dislocated.It is unknown whether the patient sustained a trauma that led to the failure.The patient's medical history and bone quality are not known.During the revision, the surgeon explanted a femoral head implant with a 28mm head and a +10.5mm taper and a guardian proximal femur implant.During the revision, the surgeon placed a femoral head implant with a 28mm head and a +10.5mm taper.The guardian proximal femur was revised with an eleos proximal femur.

Manufacturer Narrative

Additional information was provided for this failure.The root cause for the patient's hip dislocating was unable to be definitively determined.The patient's medical history is not known, and it is not known whether the patient sustained a trauma which led to the failure.The revising surgeon removed a femoral head with a +7mm taper and added a femoral head with +10.5mm of taper.This was done in an attempt to mitigate the risk of further dislocations.The patient had already dislocated their hip which led to a previous revision surgery.However, the manufacturing dhrs and sterilization records, as well as complaint and ncr history, were reviewed and no issues were found that would have contributed to this complaint.Additional mdrs for this complaint were submitted via the following reports: follow up #002.

Event Description

This report investigated a revision surgery of eleos components for a patient's whose hip dislocated twice after eleos implants were placed.Both times, eleos components were revised.This report will focus on the second revision surgery which was a result of the second instance of this patient's hip dislocating which occurred on (b)(6) 2021.This patient also underwent a previous revision surgery on (b)(6) 2021 due to their hip dislocating again.Both of these failures were not reported until (b)(6) 2021.A patient underwent a revision surgery on (b)(6) 2021 performed by dr.Sepich after a patient's hip dislocating.This was the second time the patient's hip dislocated.It is unknown whether the patient sustained a trauma that led to the failure.The patient's medical history and bone quality are not known.During the revision, the surgeon explanted a femoral head implant with a 28mm head and a +10.5mm taper and a guardian proximal femur implant.During the revision, the surgeon placed a femoral head implant with a 28mm head and a +10.5mm taper.The guardian proximal femur was revised with an eleos proximal femur.

• Brand Name: ELEOS
• Type of Device: SEGMENTAL STEM, CEMENTED, 17X120MM, STRAIGHT, FLUTED
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11671069
• MDR Text Key: 245563232
• Report Number: 3013450937-2021-00039
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2021

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
• Device Operator: Health Professional
• Device Model Number: CS-17120-03M
• Device Catalogue Number: CS-17120-03M
• Device Lot Number: 85224
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 05/18/2021; 05/18/2021
• Supplement Dates FDA Received: 06/08/2021; 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD- 26012804E; GUARDIAN PROXIMAL FEMUR- 25000001; GUARDIAN PROXIMAL FEMUR- 25000001; SEGMENTAL STEM- CS-17120-03M
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR