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

Catalog Number	02-012-35-2011
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	12/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Pending investigation.These devices are used for treatment not diagnosis.There is no other information available.
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty on 10 oct 2011 and then approximately 10 years 3 months later, on (b)(6) 2021 she experienced a surgical revision.Revision operative report of (b)(6) 2021- postoperative diagnosis: loose plastic spacer, debris synovitis, stable femur, stable tibia, stable patella with local cystic formation in tibia.Name of operation: arthrotomy, evaluation knee replacement, revision spacer, partial synovectomy, removal of debris synovitis, removal of scar tissue.The patient had gross debris synovitis throughout the knee.The plastic spacer was loosened when the knee was put into flexion; it was removed.The patient did have side-to-side play consistent with plastic debris wear.The tibia, the femur and the patella were all stable.They were not loose by mechanical evaluation and visual inspection.The patient did however have two areas on the tibia where were erosion of the cortex, one medial and one anterior with bone in between intact.The femur and patella did not show the same phenomenon.It was elected to just change the plastic spacer from an 11 to a 13.There were no intraoperative complications.No other patient information/medical history reported.No images or photos of the device are provided.The device will not be returned.No other information is available.
Additional Manufacturer Narrative
H11.Correction- after investigating, this has been discovered to be a duplicate case.All new and additional information will be appropriately captured and reported under mfr# 1038671-2022-00031.

• Brand Name: LOGIC TIBIA PS MOD INSRT
• 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 FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 18983568
• Report Number: 1038671-2024-00670
• Device Sequence Number: 2867823
• Product Code: JWH
• UDI-Device Identifier: 10885862001733
• UDI-Public: 10885862001733
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 05/22/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2019
• Device Catalogue Number: 02-012-35-2011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2011
• 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: Initial
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female