MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-48-5009
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Synovitis (2094); Joint Laxity (4526); Bursitis (4832)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported 5.5 year post initial right tka, this 64 y/o male patient was revised.Knee was leaking fluid outside capsule, possibly due to poly wear causing it but surgeon was not sure after taking liner out uncertain.Patient was last known to be in stable condition following the event.Unable to obtain photos/x-rays.Product not returning: disposed by hospital.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): 3866284 - 02-010-04-0350 - logic cr femoral por, right, sz 5 4118295 - 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t 4375898 - 200-02-38 - three peg patella 38mm 4546162 - 201-78-15 - holding pin mini sharp point 4 pk 4069058 - 201-78-81 - 3 trocar, mod.Hex 2pk 4050653 - 521-78-23 - threaded pin size 2.3 collared 4050680 - 521-78-23 - threaded pin size 2.3 collared 4492160 521-78-32 - threaded pin size 3.0 collarless 1003016045 a10012 - gps implant kit v2 9027016037 a10012 - gps implant kit v2.
Additional Manufacturer Narrative
Additional information: b4.Correction: h6 clinical codes.
Event or Problem Description
The patient has had a previous total knee replacement with a large pretibial bursa as well as a lymphocele extending down towards his ankle.Under a spinal and general anesthetic the patient was prepared on the operating table.The previous incision was utilized to dissect down to the extracapsular tissues with a large prepatellar bursa but also a lymphocele extending from the posteromedial aspect of the knee to approximately 10 cm above the ankle joint.Fluid and the lining of the lymphocele were sent for microscopy, culture and sensitivity as well as histopathology.The lymphocele was drained and the wall excised around the level of the knee and the distal extension curetted and debrided without extending the incision distally.A medial parapatellar arthrotomy was performed to reveal marked synovitis of the knee joint with some slight flexion and stability.Extensive synovectomy was performed and the 9 mm insert was exchanged to an 11 mm crc insert to ensure stability and good range of motion.The knee was irrigated with pulsatile saline lavage alternating with betadine prior to infiltrating with local anaesthetic, collatamp g and surgicel powder for additional haemostasis.A 10 mm bellovac drain was inserted into the lymphocele and the drain brought out through the superomedial aspect of the knee.The knee capsule and the remainder of layers were closed with the use of staples and a negative pressure dressing.
Additional Manufacturer Narrative
Additional information: h3: the reason for the revision cannot be confirmed from the information provided, but may be due to a combination of instability and/or patient conditions leading to fluid accumulation in the joint space.Additional information regarding the revision was provided at a later time due to inclusion of the polyethylene in the packaging recall; however, it does not appear that the reason for revision was related to prosthesis wear.However, the reported failure could not be confirmed as no images or radiographs were provided and the devices were not available for evaluation.Correction: h6: health effect clinical code, medical device problem code.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 ct; gainesville, FL 32653
• MDR Report Key: 18498602
• Report Number: 1038671-2024-00084
• Device Sequence Number: 8044718
• Product Code: JWH
• UDI-Device Identifier: 10885862174581
• UDI-Public: 10885862174581
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2024

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: 07/31/2021
• Device Catalogue Number: 02-012-48-5009
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/21/2024; 11/19/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 11/15/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2013
• 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.
• Patient Age: 64 YR
• Patient Sex: Male