MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS TIBIAL HINGE COMPONENT; PROSTHESIS, KNEE

Model Number	25002101E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The tibial hinge component was returned for further analysis and this report will be supplemented when further information is made available.
Event or Problem Description
Patient's knee gave out causing pain and dislocation of their knee.X-rays revealed that the tibial hinge component had fractured.
Event or Problem Description
Patient's knee gave out causing pain and dislocation of their knee.X-rays revealed that the tibial hinge component had fractured, which required surgical intervention.During the revision, the tibial poly spacer was also revised and was identified as damaged.
Additional Manufacturer Narrative
The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The tibial hinge component was returned for further analysis and this report will be supplemented when further information is made available.Supplement the tibial hinge component was returned and it was confirmed that the casted tibial hinge base post was fractured.A dimensional analysis was performed and confirmed that all features able to be measured for the casted tibial hinge base met specification, but the poly bumper and poly bushing subcomponents did not meet specification.These subcomponents were steam sterilized, post-revision surgery for cleaning, which alters the dimensional properties of polyethylene, which likely resulted in the subcomponents being out of specification during the analysis.Also, based upon the dhr review, these subcomponents met specification during manufacturing.Ultimately, the implant was found to be conforming during the initial surgery based upon the device history record.The failure of the tibial hinge component could not be attributed to the manufacturing of the device or a nonconformance.

• Brand Name: ELEOS TIBIAL HINGE COMPONENT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 8568959
• Report Number: 3013450937-2019-00013
• Device Sequence Number: 11147278
• Product Code: KRO
• UDI-Device Identifier: B27825002101E0
• UDI-Public: B27825002101E0
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/19/2025
• Device Model Number: 25002101E
• Device Catalogue Number: 25002101E
• Device Lot Number: 1697640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 09/06/2019
• 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: 29 YR