MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 2,; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	230-03-02
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	03/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (b)(6), 200-04-23 - cemented finned tib.Tra sz 2f/3t; (b)(6), 200-05-23 - inset patella 23mm; (b)(6), 230-03-02 - optetrak asy, cr cemented femoral, sz 2.The product associated with the reported event is within the scope of recall however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case - usa: patient id: (b)(6).On 10/3/2024: additional information received in in-box on 10/2/2024.Arthroscopy op report, and revision op report.The patient had a fall in (b)(6) of 2022.She was walking up some steps, landed on the anterior aspect of her knee, and started noticing clicking, popping, catching, and pain within her knee.Prior to that, she really did not have any major symptoms.Attached exploratory arthroscopy op report from (b)(6) of 2023 discovered synovitis, tibial component loosening, metallosis, and loose and fractured lateral tibial polyethylene.Revision surgery operative notes were provided for procedure in (b)(6) of 2023.Preoperative and postoperative diagnoses indicated failed right total knee arthroplasty due to severe polyethylene wear disease and osteolysis.Description of procedure: upon entering the joint i found the synovial lining of the joint was black due to metallosis.Inspection of the components found that the posterior aspect of the poly insert was completely worn out and a large portion of the posterior lateral tibial plate was eroded away.The previous liner was dislodged from the tibial component.I then inspected the femoral and tibial components.Both components were well fixed but had area of de bonding at the bone cement interface.The patient was revised to a competitor¿s devices.The patient tolerated the procedure well.This procedure had extra complexity due to severe osteolysis and metallosis within the joint from poly wear disease.The time required for the operation was at least 50% greater than that expected from a standard revision total knee.Additional information received from legal on 25-jul-2023: implant date: (b)(6) 2012, dr.(b)(6).Explant date: (b)(6) 2023, dr.(b)(6), op report attached.No device return anticipated due to this being a legal case.Ebi initial surgery attached.No further information.(b)(6), 200-72-09 - cr tibial insert sz 2, 9mm, slope ++.Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k082022.Concomitants: (b)(6), 200-04-23 - cemented finned tib.Tra sz 2f/3t; (b)(6), 200-05-23 - inset patella 23mm; (b)(6), 230-03-02 - optetrak asy, cr cemented femoral, sz 2.Original description summary: as reported per legal team, the 77 y/o female patient that had an original knee replacement roughly 10 years ago.The patient is needing a full knee revision due to lysis on the bone and poly wear.As of note: "sales rep was not able to locate the patient's original implant info at the original facility where it was done.The hospital is not required to keep their records past 7 years.The exactech reps 10 years ago did not put patient names on invoices, so it is difficult to narrow down this patient's information".Complaint investigation findings: the revision reported may have been the result of the overall posterior slope of the insert and/or potential ligamentous/soft tissue imbalances, which allowed for increased posterior contact between the femoral component and the tibial insert and led to the reported tibial insert wear and subsequent posterior lateral tibial tray erosion.Additionally contributing factors to the reported wear and osteolysis include implant positioning, high contact stresses during knee flexion, third body wear, or any combination of these possibilities.However, the extent of the reported osteolysis/ prosthesis wear could not be determined as the explanted tibial insert was not available for evaluation, and pre-revision radiographs and images of the explanted devices were not provided.The most probable root cause associated with the reported event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.Ebi search - no results.
Additional Manufacturer Narrative
1038671-2023-00679.1038671-2024-03822.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00679, 1038671-2024-03822.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 (type of investigation).The following sections were corrected: h6 (medical device problem code).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.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: OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 2,
• 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 66th court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20369842
• Report Number: 1038671-2024-03821
• Device Sequence Number: 19755239
• Product Code: JWH
• UDI-Device Identifier: 10885862061744
• UDI-Public: 10885862061744
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K032606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: 04/18/2017
• Device Catalogue Number: 230-03-02
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2012
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female