MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 3, 11MM, SLOPE ++; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	200-73-11
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 13a2101 - cemex system fast genta 70g, aa3614, 200-02-35 - three peg patella 35mm, 1757235, 200-04-33 - cemented finned tib.Tra sz 3f/3t, 1757906, 201-78-14 - holding pin headless sharp point long 4pk, 1711823, 201-78-15 - holding pin mini sharp point 4 pk, 1752072, 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19, 01308, asa0030 - sterile disposable containers, aa3328, correction/removal number: z-0019-2022.
Event or Problem Description
As reported by legal, this female patient had an initial right tka on (b)(6) 2010.Since then, the implant has caused her constant pain and discomfort associated with the optetrak device, including, but not limited to, polyethylene wear, bone loss, osteolysis, and/or component loosening.She requested that her surgeon treat the right knee pain caused by her optetrak device and was advised the knee replacement had failed and would require revision.The patient has experienced so much pain and discomfort in her right knee that she is fearful of obtaining a left knee replacement.The patient was revised on (b)(6) 2021.
Additional Manufacturer Narrative
H3.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
As a result from additional information provided, the following fields have been added/updated: further information and/or re-opened investigation results will be provided within 30 days of receipt.
Event or Problem Description
As reported via legal documentation, a female patient had right knee replacement surgery on (b)(6) 2010.They had revision surgery (b)(6) 2021, approximately 10 years 7 months after their initial procedure.14 jan 2021 op report indicates the patient had developed pain symptoms in association with their knee replacement.She had notable x-ray findings of a retrofemoral lysis, but no obvious signs of gross loosening of her components.Inspection of the interior of the knee revealed the patient did have moderate level of synovitis throughout the interior of the knee.There was some minor medial instability, and this was due in part to the increased wear noted on the poly insert more on the medial compartment, although there was some edge loading anterolaterally.The patient also had a large lytic lesion behind the lateral femoral condyle that was found bordering the pcl.This was quite significant and did require over 40 ml of bone graft following curettement of the defect.The patient was transported to recovery room in stable condition.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H6: investigation results - the revision reported in (b)(4) was likely the result of prothesis wear and osteolysis after being implanted for over 10 years.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 of the reported prosthesis wear and osteolysis cannot be determined as the device was not available for evaluation, and images of the explanted device and pre-revision radiographs were not provided.

• Brand Name: CR TIBIAL INSERT SZ 3, 11MM, SLOPE ++
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15877680
• Report Number: 1038671-2022-01517
• Device Sequence Number: 14792937
• Product Code: JWH
• UDI-Device Identifier: 10885862041265
• UDI-Public: 10885862041265
• 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: 2010
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/13/2023

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: 12/04/2013
• Device Model Number: 200-73-11
• Device Catalogue Number: 200-73-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/08/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 11/17/2022; 11/17/2022; 10/03/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 03/20/2023; 06/30/2023; 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2008
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female