MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; MODULAR COLLAR LOCKING RING

Model Number HR-30000-03M

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 09/28/2021

Event Type  Injury  

Manufacturer Narrative

The investigation of this event is in progress.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were reported for this event: 3013450937-2021-00234, 3013450937-2021-00236.

Event Description

It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an unknown reason.A segmental stem was requested for the revision surgery but was not implanted.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Additional information regarding this adverse event was received on (b)(6) 2021 and the investigation was concluded on 15 december 2021.The patient suffered a fall due to an unknown reason which caused soft tissue damage.The surgeon performed a soft tissue repair during the surgery and did not revise any of the eleos implants.The device was not returned for evaluation.The root cause of the patient's fall could not be determined.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that could have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections have been updated: b4: date of this report added.B5: event description updated.G3: date received by manufacturer added.G6: type of report added.H2: follow up type added.H3: device evaluated by manufacturer updated to no.H6: clinical code updated to 1848: fall.H6: clinical code updated to 4559: unspecified tissue injury.H6: type of investigation code updated to 3331: analysis of production records.H6: type of investigation code updated to 4111: communication/interviews.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4114: device not returned.H6: type of investigation code updated to 4117: device not accessible for testing.H6: type of investigation code updated to 4109: historical data analysis.H6: investigation findings code updated to 213: no device problem found.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.Multiple mdr reports were submitted for this event: #3013450937-2021-00234 #3013450937-2021-00236 #3013450937-2021-00321 #3013450937-2021-00322 #3013450937-2021-00323 #3013450937-2021-00324 #3013450937-2021-00325 #3013450937-2021-00326 #3013450937-2021-00327.

Event Description

It was reported that the patient underwent a revision surgery on (b)(6) 2021.The patient fell for an unknown reason which caused soft tissue damage to the surrounding structures of the knee.During the revision surgery, the surgeon performed a soft tissue repair.A segmental stem was requested for the revision surgery but was not implanted.No eleos implants were revised during the revision surgery.No additional information regarding this adverse event has been made available.

• Brand Name: ELEOS
• Type of Device: MODULAR COLLAR LOCKING RING
• 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
• MDR Report Key: 12655975
• MDR Text Key: 277117254
• Report Number: 3013450937-2021-00235
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278HR3000003M0
• UDI-Public: +B278HR3000003M0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

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: HR-30000-03M
• Device Catalogue Number: HR-30000-03M
• Device Lot Number: 83914R-031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: P/N 25000007E, ELEOS DISTAL FEMUR; P/N 25001050E, ELEOS MALE-FEMALE MIDSECTION 50MM; P/N 25001070E, ELEOS MALE-FEMALE MIDSECTION 70MM; P/N 25001208E, ELEOS TIBIAL POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002204E, ELEOS TIBIAL BASEPLATE; P/N HC-13120-03M, ELEOS CEMENTED STEM; P/N PB-2400R-03M, ELEOS BIOGRIP COLLAR; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT; P/N 25000007E, ELEOS DISTAL FEMUR; P/N 25001050E, ELEOS MALE-FEMALE MIDSECTION 50 MM; P/N 25001070E, ELEOS MALE-FEMALE MIDSECTION 70 MM; P/N 25001208E, ELEOS TIBIAL POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002204E, ELEOS TIBIAL BASEPLATE; P/N HC-13120-03M, ELEOS CEMENTED STEM; P/N PB-2400R-03M, ELEOS BIOGRIP COLLAR; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male