MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-5009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Synovitis (2094); Discomfort (2330); Ambulation or Postural Difficulties (2544); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) 02-010-01-0250 - logic femoral ps cem left sz 5.(b)(6) 02-012-41-5040 - logic tibia traptray cem sz 5f/4t.(b)(6) 200-02-35 - three peg patella 35mm.The product associated with the reported event is within the scope of recall z-0021-2022; 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
It was reported via legal documentation that approximately 58 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, left knee pain and stiffness.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available." (b)(6)2024: additional information received.Added concomitants.The serial number (b)(6) is confirmed to be a part of recall number: z-0021-2022.02-012-35-5009 - logic tibia ps mod insrt sz 5 9mm.Serial: (b)(6).510k: k033883.Udi: (b)(4).Product code: jwh.X-ray: no.Operative notes: yes.21-may-2024 additional information.Legal case ¿ usa (mdl no.3044).Patient id: (b)(6) + left knee.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.3044, and pending in the eastern district of new york.Per the transfer order creating this multidistrict litigation, ¿plaintiffs¿allege that their knee or hip replacement devices¿failed prematurely because of degradation of the device¿s polyethylene component which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multidistrict litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.The serial number (b)(6) is confirmed to be a part of recall number: z-0021-2022.02-012-35-5009 - logic tibia ps mod insrt sz 5 9mm.Serial: (b)(6).510k: k033883.Udi: (b)(4).Product code: jwh.X-ray: no.Operative notes: no.Concomitant devices: uknown".Original summary.Legal case - (b)(6).As reported via legal documentation a 75 y/o male patient had a left knee replacement on (b)(6) 2018.Approximately 4 years and 9 months after the initial procedure the patient had a left knee revision on (b)(6) 2022 due to pain and stiffness.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report rec'd on (b)(6) 2023.No evidence of infection.Moderate amount of reactive synovitis.Synovial fluid and deep tissue cultures were sent to microbiology.Total synovectomy was performed.The patient was transferred to the pacu in stable condition.(b)(6) 2023, (b)(6), rn ¿ the patellar button was inspected and determined to be loose, it was removed.No other information.Historical record & smartsolve searched for sn/patient name with no results.Concomitants: z-0021-2022/ (b)(6) 02-012-35-5009 logic tibia ps mod insrt serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k033883.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral debonding, prosthesis wear, and patellar loosening 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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 5 9MM
• 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 ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20677858
• Report Number: 1038671-2024-04381
• Device Sequence Number: 8949805
• Product Code: JWH
• UDI-Device Identifier: 10885862001924
• UDI-Public: 10885862001924
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: 09/02/2023
• Device Catalogue Number: 02-012-35-5009
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2015
• 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: 75 YR
• Patient Sex: Male