MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; CEMENTED FINNED TIB. TRA SZ 3F/2T

Model Number	CEMENTED CR FEMORAL SZ 3
Medical Device Problem Codes	Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923); 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	10/08/2015
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), this (b)(6) y/o, female patient underwent primary total prosthetic replacement using cement of the left knee via medial parapatellar approach on (b)(6) 2010.The indication for the index procedure was osteoarthritis.The patient was implanted with a optetrak knee system - cemented cruciate retained (cr) femoral component - size 3 (catalog 200-01-03, serial (b)(4)), optetrak knee system - cemented finned tibial tray - size 3f/2t (catalog 200-04-32, serial (b)(4)), optetrak knee system - three pegs patella - diameter 29mm (catalog 200-02-29 serial (b)(4)) and heraeus medical antibiotic loaded high viscosity bone cement (catalog 66017569, serial (b)(4)).On (b)(6) 2015, approximately 62 months post implantation, the patient underwent revision due to aseptic loosening tibia; instability; lysistibia.The exactech knee brand removed unavailable and replaced.
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, possibly secocondary to contributions from increased biomechanical stress.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.(h4) manufacture date.(h6) patient code was entered in error.This has been corrected in new submission.

• Brand Name: OPTETRAK
• Common Device Name: CEMENTED FINNED TIB. TRA SZ 3F/2T
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9712045
• Report Number: 1038671-2020-00180
• Device Sequence Number: 14027256
• Product Code: JWH
• UDI-Device Identifier: 10885862039538
• UDI-Public: 10885862039538
• 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: 2010
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• 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: 06/16/2013
• Device Model Number: CEMENTED CR FEMORAL SZ 3
• Device Catalogue Number: 200-04-32
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/15/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 58 YR