MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; BIOGRIP POROUS HA COLLAR 32MM

Model Number PB-3200R-03M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Scar Tissue (2060)

Event Date 10/06/2022

Event Type  Injury  

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: #3013450937-2022-00305, #3013450937-2022-00306, #3013450937-2022-00307, #3013450937-2022-00308, #3013450937-2022-00309, #3013450937-2022-00310, #3013450937-2022-00312, #3013450937-2022-00313, #3013450937-2022-00314.

Event Description

It was reported that the patient was experiencing loss of mobility in their knee.The patient underwent a revision surgery on (b)(6) 2022.During the revision surgery, the surgeon identified scar tissue formation.The surgeon removed the scar tissue.The surgeon took out all of the implants besides the segmental stem, collar, locking ring, and tibial baseplate, and flashed these devices then re-implanted the devices.The surgeon scheduled another revision surgery on (b)(6) 2022 in order to revise some implants and perform a washout in order to prevent an infection.On (b)(6) 2022, the surgeon revised the following implants: distal femur axial pin, poly spacer, tibial hinge component, distal femur, and male-female midsection.No additional information regarding this event has been provided.

Event Description

It was reported that the patient was experiencing loss of mobility in their knee.The patient underwent a revision surgery on (b)(6) 2022.During the revision surgery, the surgeon identified scar tissue formation.The surgeon removed the scar tissue.The surgeon took out all of the implants besides the segmental stem, collar, locking ring, and tibial baseplate, and flashed these devices then re-implanted the devices.The surgeon scheduled another revision surgery on (b)(6) 2022 in order to revise some implants and perform a washout in order to prevent an infection.On (b)(6) 2022, the surgeon revised the following implants: distal femur axial pin, poly spacer, tibial hinge component, distal femur, and male-female midsection.No additional information regarding this event has been provided.

Manufacturer Narrative

This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the adverse event could not be determined.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added.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: 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 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.

• Brand Name: ELEOS
• Type of Device: BIOGRIP POROUS HA COLLAR 32MM
• 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: 15677486
• MDR Text Key: 302467804
• Report Number: 3013450937-2022-00311
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278PB3200R03M0
• UDI-Public: B278PB3200R03M0
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PB-3200R-03M
• Device Catalogue Number: PB-3200R-03M
• Device Lot Number: 88661-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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 25001140E, ELEOS MALE-FEMALE MIDSECTION.; P/N 25001210E, ELEOS TIBIAL POLY SPACER.; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN.; P/N HC-15120-03M, ELEOS CEMENTED SEGMENTAL STEM.; P/N HR-30000-03M, ELEOS COLLAR LOCKING RING.; P/N KPONTP32E, ELEOS RESURFACING PATELLA.; P/N TB-2203E-01M, ELEOS TIBIAL BASEPLATE.; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT.
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female