MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Implant Pain (4561); Joint effusion (4849)
Date of Event	07/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal notification, that patient, underwent initial right knee replacement surgery, on (b)(6) 2011 and was implanted with a optetrak device.Specifically, plaintiff was implanted with a optetrak posterior stabilized tibial insert, along with an optetrak stem, optetrak patella, optetrak screws, a optetrak tibial tray, and a optetrak posterior stabilized femoral component.Following the surgery, plaintiff began experiencing worsening symptoms, pain, instability, effusion, and antalgic gate.Plaintiff underwent a right knee revision surgery on (b)(6) 2018, approximately 7 years 3 months post initial procedure and was implanted with a different device.Plaintiff continues to experience pain and discomfort on a daily basis in both of her knees which limits her daily activities and quality of life.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Additional information added: b5 & h6.
Event or Problem Description
Additional information received by the legal department on 19 feb 2022 "[operative report and revision operative report; relevant information]" dob: (b)(6) 1961 preoperative diagnosis for right knee arthroplasty: osteoarthritis right knee revision: preoperative diagnosis: failed right total knee arthroplasty with polyethylene wear and osteolysis.Patient revised to another company¿s devices.There was significant evidence of polyethylene wear and osteolysis especially in the region of the medial tibial plateau secondary to continued pain.Femoral component was disimpacted easily.However, there was significant cement mantle still left behind secondary to loose femoral implant.The patient was reversed from anesthesia and brought to the pacu in stable condition.Update to description summary with legal additional information "[operative reports]".Update to failure mode from pain to prosthesis wear based on preoperative diagnosis for revision of the right knee.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
D10.Concomitants: 7161 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19; 1984985 230-03-02 - optetrak asy,cr cemented femoral, sz 2; 1985218 200-04-22 - cemented finned tib.Tra sz 2f/2t ; 1991967 201-78-15 - holding pin mini sharp point 4 pk ; 2004833 201-78-14 - holding pin headless sharp point long 4pk; 2025936 200-02-32 - three peg patella 32mm.H6: investigation results - the revision reported was likely the result of prosthesis wear, osteolysis, and failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface and the reported pain.However, this cannot be confirmed as there were no details regarding cementing technique or environmental conditions provided and the device was not returned for evaluation.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear, osteolysis, and loosening could not be determined as the device was not returned for evaluation, and images and radiographs were not provided.

• Brand Name: CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++
• Common Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): Exactech, Inc; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16375799
• Report Number: 1038671-2023-00165
• Device Sequence Number: 15268617
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/01/2026

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: 02/03/2013
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 200-72-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 02/19/2023; 11/17/2023; 09/01/2026
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/27/2023; 12/07/2023; 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown