MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LGC TIBIAL FIT TRAY CEM SZ 3F / 3T
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Osteolysis (2377); Implant Pain (4561)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.D10: concomitants: 02-010-01-0230 - logic femoral ps cem left sz 3 (b)(6).02-012-44-3011 - logic tibia implant psc insert, sz 3, 11mm (b)(6).200-02-29 - three peg patella 29mm (b)(6).
Event or Problem Description
*additional information received from legal on 25sep2023*.Please see email attachment.Contents of email caused the character limit to be exceeded.Email contains product information and specifics for initial and revision surgeries.*additional information received from legal on 31jul2023*.Legal case ¿ usa (mdl no.3044).Refer to (b)(4) for fracture.8.Plaintiff was implanted with the following exactech device: optetrak logic.9.Leg in which the exactech device was implanted: left.10.Date the exactech device was implanted: (b)(6) 2014.11.State in which the exactech device was implanted: ar.12.Date the exactech device was surgically removed/revised: (b)(6) 2023.13.-plaintiff's optetrak tka system failed and required an additional surgery to remove the implant and replace it with another joint replacement system.-because she required an additional revision surgery, plaintiff has suffered significant and continuing personal injuries, is limited in her activities of daily living, requires additional physical therapy, and has incurred substantial medical bills and expenses.-as a direct, proximate, and legal consequence of the defective nature of the optetrak tka system, plaintiff has suffered and continues to suffer significant, permanent, and continuing personal injuries, as described herein.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.*original description summary* legal case carol cross- lk rev.As reported via legal documentation the patient had a left knee replacement on (b)(6) 2014.Approximately 9 years and 2 months after the initial procedure the patient had a left knee revision on 13 apr 2023.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 on 13 apr 2023.Diagnosis: failed left total knee replacement.Moderate femoral bone loss - did not require cone.Extensive tibial bone loss with a posterior fracture.There was extensive soft tissue debris throughout the knee joint consistent with a synovitis from a polyethylene reaction to the tissues.This was tiny, small balls of light brown synovium along with a "pseudo-capsule" of dense soft tissue rind.The surgeon examined the polyethylene - excessive wear was present with signs of oxidation/yellow discoloration, pitting, cracking and delamination of the poly.Distal femoral bone loss was moderate.The tibial bone loss was extensive and required placement of a tibial cone.Findings: loose femoral and tibial implants.Patient was sent to pacu in stable condition.Ebi initial surgery attached.Historical record & smartsolve searched for sn/patient name with no results.Operative report from revision surgery attached.
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 prosthesis wear, femoral loosening, and tibial 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that approximately 110 months after a left total knee replacement procedure, the patient underwent a revision procedure to address loosening, failure of implant, implant pain, osteolysis, and synovitis.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.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 3
• 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
• MDR Report Key: 20907306
• Report Number: 1038671-2024-04771
• Device Sequence Number: 18425173
• Product Code: JWH
• UDI-Device Identifier: 10885862001146
• UDI-Public: 10885862001146
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2025

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: 01/06/2019
• Device Model Number: LGC TIBIAL FIT TRAY CEM SZ 3F / 3T
• Device Catalogue Number: 02-010-01-0230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 12/10/2024; 03/20/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/06/2025; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2014
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female