MAUDE Adverse Event Report: EXACTECH, INC. OPRETRAK; CC TIBIAL INSERT SZ 2, 13MM

Model Number	208-01-02
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/05/2014
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) y/o, female patient underwent primary total prosthetic replacement using cement of the left knee via medial parapatellar approach on (b)(6) 2011.The indication for the index procedure was previous trauma.On (b)(6) 2014, approximately 30 months post implantation, the patient underwent revision due to instability and wear of polyethylene component.The follow-ups for additional information cannot be performed for this complaint, information was submitted as complete by the (b)(6); there is no identification of facilities or surgeons.All available information about the event and/or patient has been provided.These devices are used for treatment not diagnosis.Total knee replacement instability is noted to occur due to surgical techniques of creating excessive flexion gaps, inadequate filling of the extension space due to the components not being thick enough, soft tissue/ligament damage, and/or injury incurred during post-op rehabilitation therapy.Musculoskeletal key, (2018, october).Treatment of instability after total knee replacement; electronic source.
Additional Manufacturer Narrative
The evaluation noted that revision reported was likely the result of a combination of multiple patient-related conditions contributing to tibial insert wear.However, this cannot be confirmed because the component was not returned for evaluation and no additional first-hand details or radiographs were provided.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 no information provided in the following section(s): a4, a5, and b6.The following section(s) have additional info: d2, d4 (catalog number, serial number, exp date, and udi number), g4, g5, g7, h1, h2, h3, h4 h6, and h7.Section h11: corrections made in the following section(s): (d2) common device name.(d4) catalog number, serial number, exp date, and udi number.(g5) 510k number.(h6) evaluation codes.

• Brand Name: OPRETRAK
• Common Device Name: CC TIBIAL INSERT SZ 2, 13MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9706476
• Report Number: 1038671-2020-00108
• Device Sequence Number: 19746404
• Product Code: JWH
• UDI-Device Identifier: 10885862053213
• UDI-Public: 10885862053213
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• 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: 01/27/2014
• Device Model Number: 208-01-02
• Device Catalogue Number: 208-22-13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 02/13/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR