MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; MALE-FEMALE MIDSECTION, 70MM

Model Number	25001070E
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the patient's hip dislocating was unable to be determined.Due to the surgeon's shortening of the limb during the revision, the limb length may have been a contributing factor to the hip dislocation.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 or the sterilization of the implants or a nonconformance.
Event or Problem Description
A (b)(6) -year-old female patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) due to the patient's hip dislocating.The patient had a proximal femur implant and a male-female midsection placed during her previous revision surgery which occurred on (b)(6) 2020.During the revision on (b)(6) 2021, the surgeon replaced the male-female midsection and the proximal femur implant.The male-female midsection that was explanted was 70 millimeters.This was replaced with a 60mm male-female midsection.The sales representative stated that this was done in an attempt to mitigate the risk of future dislocations.
Event or Problem Description
A 72-year-old female patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) due to the patient's hip dislocating.The patient had a proximal femur implant and a male-female midsection placed during her previous revision surgery which occurred on (b)(6) 2020.During the revision on (b)(6) 2021, the surgeon replaced the male-female midsection and the proximal femur implant.The male-female midsection that was explanted was 70 millimeters.This was replaced with a 60mm male-female midsection.The sales representative stated that this was done in an attempt to mitigate the risk of future dislocations.
Additional Manufacturer Narrative
The incorrect implatn was originally reported.The proximal femur implant had no failure reported by the sales representative or the surgeon.The male-female midsection was revised to decrease the length of the segment in an attempt to mitigate the risk of further dislocations of the hip.Dates of previous surgeries were corrected as they were originally reported with the incorrect dates.

• Brand Name: ELEOS
• Common Device Name: MALE-FEMALE MIDSECTION, 70MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11604588
• Report Number: 3013450937-2021-00030
• Device Sequence Number: 19887660
• Product Code: KRO
• UDI-Device Identifier: B278PF2000L02M0
• UDI-Public: B278PF2000L02M0
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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 Model Number: 25001070E
• Device Catalogue Number: 25001070E
• Device Lot Number: 1833876
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 04/06/2021
• 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: 72 YR