MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; PROXIMAL FEMUR, RIGHT, 98MM

Model Number	PF-2000R-02M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's femoral head dislocated.The patient underwent a revision surgery where the following eleos implants were revised: two male-female midsections and proximal femur.The patient's femoral head was manufactured by a different company and was also revised during this revision surgery.The two 40mm eleos male-female midsections were revised to a 70mm eleos male-female midsection.No additional information regarding this adverse event has been reported.
Additional Manufacturer Narrative
The investigation is in process.The device will not be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: #3013450937-2023-00102.#3013450937-2023-00103.
Event or Problem Description
It was reported that the patient's femoral head dislocated.The patient underwent a revision surgery where the following eleos implants were revised: two male-female midsections and proximal femur.The patient's femoral head was manufactured by a different company and was also revised during this revision surgery.The two 40mm eleos male-female midsections were revised to a 70mm eleos male-female midsection.No additional information regarding this adverse event has been reported.
Additional Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The device history records and sterilization batch records were reviewed and there were no non-conformances identified that would have contributed to this adverse event.If additional information is obtained, a supplemental mdr will be filed accordingly.

• Brand Name: ELEOS
• Common Device Name: PROXIMAL FEMUR, RIGHT, 98MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17148512
• Report Number: 3013450937-2023-00104
• Device Sequence Number: 5589859
• Product Code: JDI
• UDI-Device Identifier: B278PF2000R02M0
• UDI-Public: B278PF2000R02M0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K203090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: PF-2000R-02M
• Device Catalogue Number: PF-2000R-02M
• Device Lot Number: 90750-022
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• 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: P/N 25001040E, ELEOS MALE-FEMALE MIDSECTION.; P/N 25001040E, ELEOS MALE-FEMALE MIDSECTION.; P/N CB-13152-03M, ELEOS SEGMENTAL STEM.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male