MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL CEM, RIGHT, SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Ankylosis (4527); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/14/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2013.Approximately 2 years and 8 months after the initial procedure the patient had a right knee revision on (b)(6) 2015.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.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.
Additional Manufacturer Narrative
D10.Concomitants: 02-012-49-5009 - logic cr tib insert slope++, sz 5, 9mm 2298729.02-010-03-0350 - logic cr femoral cem, right, sz 5 2080781.02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t 2539278.200-02-38 - three peg patella 38mm 2251683.Further information and or investigation results will be provided within 30 days of receipt.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2013 due to end stage osteoarthritis.Approximately 2 years and 8 months after the initial procedure the patient had a right knee revision on (b)(6) 2015.Revision op report postoperative diagnosis: fibrous ankylosis, right knee, with loose femoral component.The surgeon noted that after resection of the posterior cruciate and notch, the component appeared to be intact, but on gentle manipulation it easily loosened removing the metal from the overlying cement that stayed on the bone.The tibial base was still intact and left alone.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.
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 loss of range of motion, 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 CR FEMORAL CEM, RIGHT, SZ 5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17772085
• Report Number: 1038671-2023-02303
• Device Sequence Number: 17932830
• Product Code: JWH
• UDI-Device Identifier: 10885862158147
• UDI-Public: 10885862158147
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• 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,Followup
• Report Date (Section B): 01/02/2025

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: 06/16/2021
• Device Model Number: N/A
• Device Catalogue Number: 02-010-03-0350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 09/13/2023; 12/30/2024
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/31/2023; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2011
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male