MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	208-25-13
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report number 1038671-2023-00395 for revision referenced in spring 2017.Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via legal notification, that patient, in spring 2017, underwent a revision surgery on his right knee for issues including but not limited to polyethylene wear, bone loss, osteolysis, instability, and/or component loosening.In fall 2022, approximately 5 years post revision procedure, plaintiff underwent a revision surgery on his right knee for issues including but not limited to polyethylene wear, bone loss, osteolysis, instability, and/or component loosening.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
Report number: 1038671-2024-04444.A2: corrected the following: date of birth.A3: corrected the following: gender.B1: corrected the following: type of report.D1/d2b: corrected the following: brand name, common device name.D4: corrected the following: catalog number, expiration date, serial number, unique identifier (udi) #.D6b: corrected the following: if explanted, give date.G1: corrected the following: reporting contact name prefix/title (dr., mrs., etc.), reporting contact first name, reporting contact last name.G1: added the following: reporting contact address line 1, reporting contact us city, reporting contact state (select from fda approved list), reporting contact us zip code (b)(6) or foreign, postal code (10 digits), reporting contact country (select from fda approved list).G3/4: corrected the following: pma/510(k)number.H4: corrected the following: device manufacture date.H6: corrected the following: health effect - clinical code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusions.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: CC TIBIAL INSERT SZ 5, 13MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16504761
• Report Number: 1038671-2023-00396
• Device Sequence Number: 12317330
• Product Code: JWH
• UDI-Device Identifier: 10885862054425
• UDI-Public: 10885862054425
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: 04/17/2018
• Device Catalogue Number: 208-25-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male