MAUDE Adverse Event Report: EXACTECH, INC. CEMENTED FINNED TIB. TRA SZ 4F/4T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitants medical product(s): (b)(4), 200-04-44 - cemented finned tib.Tra sz 4f/4t, (b)(4), 234-03-04 - optetrak asy,ps cemented femoral, sz 4, (b)(4), 200-02-38 - three peg patella 38mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a legal notification, that patient, underwent initial right knee replacement surgery on (b)(6) 2010 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) 2020, approximately 10 years 4 months post initial procedure.Plaintiff continues to experience pain and discomfort on a daily basis in his right knee which limits his daily activities and quality of life.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
D2b.Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer d10.Concomitant: 1431623 204-24-09 - ps tibial inserts sz 4, 9mm d4.All items; d10.1572418 234-03-04 - optetrak asy,ps cemented femoral, sz 4.
Event or Problem Description
Additional information received to the legal department on 27 feb 2023: preoperative diagnosis for 7 dec 2020 ¿ loosening of prosthesis of right total knee replacement, wear articular bearing surface internal prosthetic right knee joint.Revision of total right knee replacement operative report (b)(6) 2020 [relevant information]:  the patient presented with increasing pain and swelling.Patient revised to another company knee system.The synovium was found to be full of reactive tissue consistent with poor polyethylene.Four deep tissue samples were taken.The patella button was found to be well fixed and was not revised.The tibial polyethylene was removed, and it showed significant oxidation and delamination.The femoral component was removed with minimal bone loss except in the anterior flange.The bone underneath it was reactive and inflamed but did not show signs of significant bone loss.The tibial implant spontaneously popped off the tibia as the retractors were placed.The cement under the tibia was partially intact, when removed a very large cystic and osteolytic lesion on the proximal tibia was debrided.Procedure was tolerated well.  there is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d1, d2a, d2b, d4, g3, g4, h4, h6 the following sections were corrected: d4, h4, h6 mdr section codes updated/corrected: a, b, c, d, e, g the reason for the revision reported cannot be confirmed from the information provided but may be the result of tibial loosening, instability, and prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CEMENTED FINNED TIB. TRA SZ 4F/4T
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16366479
• Report Number: 1038671-2023-00137
• Device Sequence Number: 7390655
• Product Code: JWH
• UDI-Device Identifier: 10885862039767
• UDI-Public: 10885862039767
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2013
• Device Model Number: N/A
• Device Catalogue Number: 200-04-44
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 02/27/2023; 12/20/2024
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/23/2023; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2008
• 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.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male