MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL-FILLING SEGMENTAL STEM, 13X120MM, STRAIGHT, SPLINED

Model Number	FS-13120-03M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented multiple times with knee effusions.The surgeon drew fluid from the knee.The fluid was analyzed and showed increased levels of cobalt, titanium, and chromium.The patient underwent a revision surgery on (b)(6) 2021.The surgeon decided to re-implant the zimmer biomet compress.No additional information regarding this adverse event has been reported.
Additional Manufacturer Narrative
The investigation is in process.The device has been returned for evaluation on 02 february 2022 and is being included in this complaint investigation.The returned device will be undergoing further testing at an approved supplier.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.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: #3013450937-2021-00336.#3013450937-2021-00337.
Event or Problem Description
It was reported that the patient presented multiple times with knee effusions.The surgeon drew fluid from the knee.The fluid was analyzed and showed increased levels of cobalt, titanium, and chromium.The patient underwent a revision surgery on (b)(6) 2021.The surgeon decided to re-implant the zimmer biomet compress.No additional information regarding this adverse event has been reported.
Additional Manufacturer Narrative
The investigation is complete.It was determined that the returned devices could not be furher evaluated.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 additional information is received, a supplemental mdr will be submitted accordingly.

• Brand Name: ELEOS
• Common Device Name: CANAL-FILLING SEGMENTAL STEM, 13X120MM, STRAIGHT, SPLINED
• 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: 13581550
• Report Number: 3013450937-2022-00104
• Device Sequence Number: 20254105
• Product Code: KRO
• UDI-Device Identifier: B278FS1312003M0
• UDI-Public: B278FS1312003M0
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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: FS-13120-03M
• Device Catalogue Number: FS-13120-03M
• Device Lot Number: 85212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2019
• 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 25000007E, ELEOS DISTAL FEMUR; P/N 25001040E, ELEOS MALE-FEMALE MIDSECTION; P/N 25001208E, ELEOS TIBIAL POLY SPACER; P/N 25002100E, ELEOS TIBIAL HINGE COMPONENT; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002201E, ELEOS TIBIAL BASEPLATE; P/N KPONTP32E, ELEOS RESURFACING PATELLA; P/N KSP13100E, ELEOS CANAL FILLING STEM EXTENSION; P/N KTAGB110E, ELEOS TIBIAL BLOCK AUGMENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female