MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-51-3009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994); Scar Tissue (2060); Synovitis (2094); Anxiety (2328); Discomfort (2330); Ambulation or Postural Difficulties (2544); Implant Pain (4561); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant devices: serial number: (b)(6), item number and full description: 02-010-03-0330 - logic cr femoral cem, right, sz 3.Serial number: (b)(6), item number and full description, 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.Serial number: (b)(6), item number and full description: 200-03-35 - one peg patella 35mm.Serial number: (b)(6), item number and full description: 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.Serial number: (b)(6), item number and full description: 02-010-03-0230 - logic cr femoral cem, left, sz 3.Serial number: (b)(6), item number and full description: 200-03-35 - one peg patella 35mm.Serial number: (b)(6), item number and full description: 201-78-81 - 3" trocar, mod.Hex 2pk.The device was not returned for evaluation and no photographs or x-rays were provided for review; therefore the reported event cannot be confirmed through analysis.No operative notes were provided; therefore, a review of device usage and technique could not be performed.No information concerning patient conditions, co-morbidities, or other health or anatomical concerns was provided and it is therefore unknown if patient-related factors may have caused or contributed to the reported event.The cause of the reported event cannot be determined based on the information made available.Should additional, relevant information become available, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that approximately 31 months after a left total knee replacement procedure, the patient underwent a revision procedure to address polyethylene wear, severe pain, significant scarring, swelling, effusion, inflammation, knee popping/clunking, knee giving away, difficulty walking, antalgic gait, and synovitis.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: b2, h6.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear 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, radiographs, and relevant clinical information 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 TIB INSERT IMPL CRC, SZ 3, 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19237790
• Report Number: 1038671-2024-01033
• Device Sequence Number: 18169459
• Product Code: JWH
• UDI-Device Identifier: 10885862230409
• UDI-Public: 10885862230409
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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 Catalogue Number: 02-012-51-3009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown