MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-3011
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that the patient had an initial left total knee arthroplasty on (b)(6) 2013, then approximately 8 years, 7 months later, on (b)(6) 2022 was surgically revised.Revision operative report of (b)(6) 2022: failed left total knee replacement.Revision of tibial and femoral implants.Findings: severe amount of distal femoral and posterior lateral proximal tibial bone loss.Severe amount of poly wear present on the polyethylene-there was a walnut size area of proximal bone loss due to osteolysis along the proximal posterior tibial -base plate was grossly loose.Along the posterior distal femur and the anterior lateral femoral implant there was severe bone loss as a result of osteolysis.Soft tissue throughout the knee joint had signs of severe osteolysis as well.Grossly lose femoral and tibial implants- removed easily with minimal bone loss.Revised to competitor¿s devices.The patient was sent to pacu instable condition.There were no intraoperative complications.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 other information is available.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10.Concomitants: (b)(6); 02-010-01-0230 - logic femoral ps cem left sz 3; (b)(6); 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t; (b)(6); 200-02-32 - three peg patella 32mm.These devices are used for treatment not diagnosis.There is no other information available.Pending investigation.
Additional Manufacturer Narrative
Recall number: z-0021-2022 this follow-up report is being submitted to relay additional and/or corrected information.D10: concomitants: 2846322 02-010-01-0230 - logic femoral ps cem left sz 3, 2819526 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t, 2730475 200-02-32 - three peg patella 32mm.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-04758, 1038671-2024-04756.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 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.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 11MM
• 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 ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17756770
• Report Number: 1038671-2023-02278
• Device Sequence Number: 12555747
• Product Code: JWH
• UDI-Device Identifier: 10885862173560
• UDI-Public: 10885862173560
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: 08/21/2019
• Device Catalogue Number: 02-012-44-3011
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2012
• 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: SEE H10; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female