MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; CEMENTED FINNED TIB. TRA SZ 5F/4T

Model Number	PS CEMENTED FEMORAL SZ 5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by (b)(6) registry ((b)(6)), this (b)(6) y/o, 183 cm, (b)(6) kg (bmi=24), male 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 optetrak knee system - cemented posterior stabilised (ps) femoral component - size 5 (catalog 204-01-05, serial (b)(4)), optetrak knee system - cemented finned tibial tray - size 5f/4t (catalog 200-04-54, serial 1462007), optetrak knee system - posterior stabilised (ps) tibial insert - size 5 - 13mm (catalog 204-25-13, serial 1153163) and heraeus medical antibiotic loaded high viscosity bone cement (catalog 66017569, serial (b)(4)).On (b)(6) 2015, approximately 45 months post implantation, the patient underwent revision due to aseptic loosening tibia.The exactech knee brand removed unavailable and replaced with optetrak offset tibial tray 5f/4t beta, optetrak knee system - posterior stabilised (ps) tibial insert - size 5 - 18mm and optetrak knee system - three pegs patella - diameter 38mm.
Additional Manufacturer Narrative
Section h10: (h3) 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 (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.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 5F/4T
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9714897
• Report Number: 1038671-2020-00198
• Device Sequence Number: 2295685
• Product Code: JWH
• UDI-Device Identifier: 10885862047601
• UDI-Public: 10885862047601
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: 04/15/2014
• Device Model Number: PS CEMENTED FEMORAL SZ 5
• Device Catalogue Number: 200-04-54
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 05/08/2020
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 80