MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-2011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Osteolysis (2377); Implant Pain (4561)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 02-010-01-0320 - logic femoral ps cem right sz 2 2818197; 02-012-45-2010 - lgc tibial fit tray cem sz 2f / 1t 2503474; 200-02-29 - three peg patella 29mm 2584462; 201-78-25 - small headed sharp pin, 1 1/8" 4 pack 2659897; pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2013.Approximately 9 years and 4 months after the initial procedure the patient had a right knee revision on (b)(6) 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 (b)(6) 2023 diagnosis: failed right knee replacement findings: loose femoral and tibial implants - removed easily with moderate bone loss.Very large posterior medial fluid collection - thick viscous light brown - unusual appearance likely related to severe poly wear.There was extensive soft tissue debris throughout the knee joint consistent with a synovitis from a polyethylene reaction to the tissues.There was tiny, small balls of light brown synovium along with a "pesudo-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.
Additional Manufacturer Narrative
Recall number: z-0021-2022.1038671-2024-04776, 1038671-2024-04775.D10: concomitants: 02-010-01-0320 - logic femoral ps cem right sz 2 (b)(6).02-012-45-2010 - lgc tibial fit tray cem sz 2f / 1t (b)(6).200-02-29 - three peg patella 29mm (b)(6).201-78-25 - small headed sharp pin, 1 1/8" 4 pack (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-04776, 1038671-2024-04775.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.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g1, h6.The following sections were corrected: b1, b2, g1, h6.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 2, 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 ct.; gainesville FL
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 18517447
• Report Number: 1038671-2024-00090
• Device Sequence Number: 6545329
• Product Code: JWH
• UDI-Device Identifier: 10885862173485
• UDI-Public: 10885862173485
• 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: 2013
• 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
• 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: 07/26/2019
• Device Catalogue Number: 02-012-44-2011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2011
• 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: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female