MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 15MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Synovitis (2094)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per a report from the legal department the male patient had a left knee replacement on (b)(6) 2014.Approximately 8 years and 11 months after the initial procedure the patient had a left knee revision on (b)(6) 2023 due to pain.Revision op report - (b)(6) 2023 patient had severe pain due to failed aseptic loosening of left total knee replacement.Loose femoral and tibial implants - removed easily with moderate bone loss.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 resected as much of this as safely possible.The total amount of soft tissue damage that required resection was ~ 6 oz.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.This did not require a femoral cone.Large medium grape size bone defect (uncontained) along the medial posterior tibia as a result of osteolysis.The tibial bone loss was extensive and required placement of a tibial cone.Patient reversed from anesthesia and sent to pacu in stable condition.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
D10: concomitants: 2291002: 02-010-01-0240 - logic femoral ps cem left sz 4.2921741: 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.2917632: 200-02-35 - three peg patella 35mm.Pending investigation.
Additional Manufacturer Narrative
Additional information: d7a f6/f8 - should be blank.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of prosthesis wear, osteolysis, and an insufficient bond between the implants and the bones, which led to aseptic (non-infected) femoral and tibial loosening, as stated in the operative notes.The extent and root cause of the prosthesis wear, osteolysis, and loosening could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 15MM
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16824050
• Report Number: 1038671-2023-00851
• Device Sequence Number: 17896243
• Product Code: JWH
• UDI-Device Identifier: 10885862173669
• UDI-Public: 10885862173669
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2023

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: 07/08/2019
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 15MM
• Device Catalogue Number: 02-012-44-4015
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 04/06/2023; 09/21/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 05/16/2023; 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2011
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Unknown