MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; CEMENTED FINNED TIB. TRA SZ 3F/3T

Model Number	230-03-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/01/2019
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) y/o, female patient underwent primary total prosthetic replacement using cement of the right knee via medial parapatellar approach on (b)(6) 2011.The indication for the index procedure was osteoarthritis.The patient was implanted with a asymmetric femoral cruciate retained cemented size 3 right (catalog 230-03-03, serial (b)(4)), optetrak knee system - cemented finned tibial tray - size 3f/3t (catalog 200-04-33, serial (b)(4)), optetrak knee system - cruciate retained (cr) tibial insert - size 3 - 13mm (catalog 200-23-13, serial (b)(4)) and heraeus medical antibiotic loaded high viscosity bone cement (catalog 66017569, serial (b)(4)).On (b)(6) 2019, approximately 105 months post implantation, the patient underwent revision due to aseptic loosening femur; aseptic loosening tibia.The exactech femoral component removed; tibial component removed; tibial liner component removed and replaced with sigma femoral posterior stabilized cemented size 3 right, mbt revision tibial tray cemented size 3 and rotating platform stabilised tibial insert size 3 15.0mm.
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) loosening.However, 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 united kingdom national joint registry (uknjr).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 no information provided in the following section(s): a4, a5, and b6.The following section(s) have additional info: d2, d4 (catalog number, serial number, exp date, and udi number), g4, g5, g7, h1, h2, h3, h4, h6, and h7.Section h11: corrections made in the following section(s): (d2) common device name.(d4) catalog number, serial number, exp date, and udi number.(g5) 510k number.(h4) manufacture date.(h6) evaluation codes.

• Brand Name: OPTETRAK
• Common Device Name: CEMENTED FINNED TIB. TRA SZ 3F/3T
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9714746
• Report Number: 1038671-2020-00192
• Device Sequence Number: 19407003
• Product Code: JWH
• UDI-Device Identifier: 10885862061751
• UDI-Public: 10885862061751
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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: 12/14/2015
• Device Model Number: 230-03-03
• Device Catalogue Number: 200-04-33
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 05/13/2020
• 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: 66 YR