MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; ASY,CR CEMENTED FEMORAL, SZ 2,

Model Number	230-03-02
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This submission represents 1 of 163 events identified via active surveillance activities utilizing data form the (b)(6).Follow-ups for additional information cannot be performed for this complaint as the information was submitted as complete by the registry; there is no identification of facilities or surgeons.All available information about the event and/or patient has been provided and it is not possible to obtain any of the devices.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by (b)(6), this (b)(6), female patient underwent primary total prosthetic replacement using cement of the right knee via medial parapatellar approach on (b)(6) 2010.The indication for the index procedure was osteoarthritis.The patient was implanted with a cruciate retaining cemented femoral asymmetrical components (size 2 right) (catalog 230-03-02, serial (b)(4)), optetrak knee system - cemented finned tibial tray - sizes 1f/2t 2f/2t (catalog 200-04-22, serial (b)(4)), optetrak knee system - cruciate retained (cr) tibial insert - size 2 - 11mm (catalog 200-22-11, serial (b)(4)) and heraeus medical antibiotic loaded high viscosity bone cement (catalog 66017569, serial (b)(4)).On (b)(6) 2016, approximately 71 months post implantation, the patient underwent revision due to aseptic loosening femur; aseptic loosening tibia; instability.The exactech knee brand removed unavailable and replaced with sigma femoral ps non-lugged cemented size 2 right, mbt revision tibial tray cemented size 2 and rotating platform stabilised tibial insert size 2 12.5mm,.
Event or Problem Description
As reported by united kingdom national joint registry (uknjr), this 55 y/o, female patient underwent primary total prosthetic replacement using cement of the right knee via medial parapatellar approach on (b)(6) 2010.The indication for the index procedure was osteoarthritis.On (b)(6) 2016, approximately 71 months post implantation, the patient underwent revision due to aseptic loosening of the femur and tibia, and instability.The follow-ups for additional information cannot be performed for this complaint, information was submitted as complete by the (b)(6); there is no identification of facilities or surgeons.All available information about the event and/or patient has been provided.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
The evaluation noted that revision reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) femoral and tibial loosening.It is unclear if the instability contributed to the loosening or if the loosening caused the instability.This cannot be confirmed since the devices were not returned for evaluation.This submission represents 1 of 163 events identified via active surveillance activities utilizing data form the (b)(6).Follow-ups for additional information cannot be performed for this complaint as the information was submitted as complete by the registry; there is no identification of facilities or surgeons.All available information about the event and/or patient has been provided and it is not possible to obtain any of the devices.

• Brand Name: OPTETRAK
• Common Device Name: ASY,CR CEMENTED FEMORAL, SZ 2,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9713687
• Report Number: 1038671-2020-00189
• Device Sequence Number: 2295679
• Product Code: JWH
• UDI-Device Identifier: 10885862061744
• UDI-Public: 10885862061744
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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 Expiration Date: 07/19/2015
• Device Model Number: 230-03-02
• Device Catalogue Number: 230-03-02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 04/30/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 55 YR