MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; CR FEMORAL CEM, LEFT, SZ 4

Model Number	02-010-03-0240
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/03/2018
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), male patient underwent primary total prosthetic replacement using cement of the left knee via medial parapatellar approach on (b)(6)2013.The indication for the index procedure was osteoarthritis.The patient was implanted with a logic - cruciate retaining - cemented femoral component - left - size 4 (catalog 02-010-03-0240, serial (b)(4)), logic - fit - cemented tibial tray - size 4f/4t (catalog 02-012-45-4040, serial (b)(4)), logic - cruciate retaining tibial insert - size 4 11mm slope ++ (catalog 02-012-49-4011, serial (b)(4)) and stryker antibiotic loaded medium viscosity bone cement (catalog 61971001, serial (b)(4)).On (b)(6) 2018, approximately 53 months post implantation, the patient underwent revision due to aseptic loosening patella.The exactech knee brand removed unavailable and replaced with gii oval resurfacing pat 32mm.
Additional Manufacturer Narrative
Section h10: (h3) the engineering evaluation noted the revision reported was likely the result of patella loosening.However, this cannot be confirmed since the devices were not returned for evaluation and no information regarding the patella component originally implanted was provided.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.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: CR FEMORAL CEM, LEFT, SZ 4
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9715036
• Report Number: 1038671-2020-00208
• Device Sequence Number: 2139775
• Product Code: JWH
• UDI-Device Identifier: 10885862158031
• UDI-Public: 10885862158031
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 10/31/2023
• Device Model Number: 02-010-03-0240
• Device Catalogue Number: 02-010-03-0240
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 04/29/2020
• 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: 59 YR