MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 5,

Model Number	OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 5,
Medical Device Problem Codes	Loss of Osseointegration (2408); 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	09/22/2017
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), this (b)(6), 178 cm, (b)(6) (bmi=35), male patient underwent primary total prosthetic replacement using cement of the left knee via medial parapatellar approach on (b)(6) 2012.The indication for the index procedure was osteoarthritis.The patient was implanted with a cruciate retaining cemented femoral asymmetrical component size 5 left (catalog 230-02-05, serial (b)(4)), optetrak knee system - cemented finned tibial tray - size 5f/4t (catalog 200-04-54, serial (b)(4)), optetrak knee system - cruciate retained (cr) tibial insert - size 5 - 9mm (catalog 200-25-09, serial (b)(4)), optetrak knee system - three pegs patella - diameter 35mm (catalog 200-02-35, serial (b)(4)) and heraeus medical antibiotic loaded high viscosity bone cement (catalog 66017569, serial (b)(4)).On (b)(6) 2017, approximately 65 months post implantation, the patient underwent revision due to aseptic loosening femur; aseptic loosening tibia; lysistibia; other indication for revision.The exactech were removed and replaced.
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) femoral and tibial loosening and osteolysis.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.Section h11: corrections made in the following section(s): (a1) patient identifier has been updated.(d1) brand name.(d2) common device name.(d4) model number was entered in error.Please disregard.(h6) patient code was entered in error.This has been corrected in new submission.

• Brand Name: OPTETRAK
• Common Device Name: OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 5,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9715004
• Report Number: 1038671-2020-00203
• Device Sequence Number: 13988216
• Product Code: JWH
• UDI-Device Identifier: 10885862061706
• UDI-Public: 10885862061706
• 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: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,study
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2014
• Device Model Number: OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 5,
• Device Catalogue Number: 230-02-05
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 110