MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 9MM

Model Number 204-22-09

Device Problem Degraded (1153)

Patient Problem Failure of Implant (1924)

Event Date 11/29/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that a (b)(6) patient at 94 kg experienced a left knee revision surgery on (b)(6) 2016, due to prosthesis wear.Initial surgery date was (b)(6) 2007.No additional information about the event or patient has been provided.These devices are used for treatment not diagnosis.It is found in a review of the labeling and ifu 700-096-004 rev.N, it is known that device specific risks consist of: fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, any of which may require a second surgical intervention or revision.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Revisions or surgical interventions are a known complication found in joint replacements.All patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery.The patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.The surgeon must be fully knowledgeable about all aspects of the surgical technique to use the implants in accordance with the indications and contraindications and be trained according to the proper use of the system instrumentation and implants.It is a known complication that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.As noted in "why are total knee arthroplasties failing today - has anything changed after 10 years?", the top five reasons for total knee arthroplasty revision/surgical intervention account for approximately 85% of the reasons that drive revision/surgical intervention.The failure mechanisms are as follows: 39.9% for loosening; 27.4% for infection; 7.35% for instability; 4.7% for periprosthetic fracture; and 4.5 % for arthrofibrosis.In early revisions (less than two years) infection was found to be the most common failure mechanism and late revisions show aseptic loosening as the most common reason.1 1.Sharkey, p.L.(2014, september).Why are total knee arthroplasties failing today - has anything changed after 10 years?; the journal of arthroplasty, 29.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The revision reported was likely the result of excessive tibial insert wear.The underlying cause of the wear cannot be determined because the component was not returned for evaluation and no x-rays were provided.This patient has a bmi of 35 which is considered obese; this may add biomechanical stressors to the knee replacement and affect performance.This event is being reported as part of a large group of mdr reportable events (386) received from the hospital for specialty surgery (hss).Exactech engineering became aware of unreported revisions of exactech knee product via a published abstract and poster (paper 640 what happened? extreme delamination and oxidation in modern day compression molded polyethylene brian t.Nickel, md, new york, ny lydia weitzler, ms, new york, ny douglas e.Padgett, md, new york, ny timothy m.Wright, phd, new york, ny.Exactech engineering requested access to the hss's details regarding the data used for the publication.The knee engineering team received raw data from hss documenting 386 mdr reportable events (revisions) that occurred at hss from 2001 through january 2018.Hss did not report these events individually to exactech at the time of the revisions.Exactech engineering forwarded the information to the exactech complaint handling unit.Each individual event has been added to the complaint data and investigated.Capa (b)(4) was opened to address this issue and to investigate and report these events.As part of the capa, a risk assessment was conducted to compare the rate of knee revisions before and after adding the additional revisions from hss to the complaint data.The risk assessment concluded that the overall occurrence rate remains at a rating of very low (1) per exactech's risk management procedure.The overall risk profile of the device has not changed.

Event Description

It was reported that a (b)(6) patient at 94 kg experienced a left knee revision surgery on (b)(6) 2016, due to prosthesis wear.Initial surgery date was (b)(6) 2007.No additional information about the event or patient has been provided.

• Brand Name: PS TIBIAL INSERTS SZ 2, 9MM
• Type of Device: PS TIBIAL INSERTS SZ 2, 9MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 10946532
• MDR Text Key: 219562086
• Report Number: 1038671-2020-10301
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862048226
• UDI-Public: 10885862048226
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K933610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2011
• Device Model Number: 204-22-09
• Device Catalogue Number: 204-22-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PS CEMENTED FEMORAL,SZ 2; THREE PEG PATELLA, 32MM; TRAPEZOID TIBIAL TRAY SZ, 1F/2T, 2F/2T
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 71 YR
• Patient Weight: 94