MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 4, 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint effusion (4849)
Date of Event	04/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6)2015.Approximately 7 years and 2 months after the initial procedure the patient had a left knee revision on (b)(6) 2022.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) 2022.Diagnosis: failed left knee arthroplasty due to recurrent effusions from polyethylene and flexion instability - femoral component found to be debonded "copious straw-colored synovial fluid was obtained.I then sent synovial specimens for culture as well as frozen pathology.A generous medial peel was performed to assist with exposure.A partial synovectomy was performed to reestablish the medial and lateral gutters.Next, the polyethylene was removed with an osteotome.There was no gross evidence of polyethylene wear.The femur was then easily able to be disimpacted.The implant was found to be completely de bonded from the underlying cement." the patient was roused from anesthesia, having tolerated the procedure well without complication.He was brought to pacu in stable condition.
Additional Manufacturer Narrative
D10: concomitants: 02-012-49-5013 - logic cr tib insert slope++, sz 5, 13mm, (b)(6); 02-010-03-0240 - logic cr femoral cem, left, sz 4, (b)(6); 02-010-03-0350 - logic cr femoral cem, right, sz 5, (b)(6); 02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t, (b)(6); 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t, (b)(6); 200-02-38 - three peg patella 38mm, (b)(6); 200-02-38 - three peg patella 38mm, (b)(6); 201-78-15 - holding pin mini sharp point 4 pk, (b)(6); 201-78-82 - collar fixation pin 2pk 40mm, quick release, (b)(6); 201-78-89 - 3" drill bit, mod.Hex 2 pack, (b)(6); 201-78-89 - 3" drill bit, mod.Hex 2 pack, (b)(6).Pending investigation.
Additional Manufacturer Narrative
Correction to h6 clinical codes and h6 component code.
Additional Manufacturer Narrative
H6: corrected the following: medical device problem codes, type of investigation, investigation findings, investigation conclusions manufacturer narrative updated: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and femoral loosening or due to inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear, instability, and femoral loosening could not be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 4, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17335351
• Report Number: 1038671-2023-01680
• Device Sequence Number: 15072336
• Product Code: JWH
• UDI-Device Identifier: 10885862230508
• UDI-Public: 10885862230508
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2024

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: 11/01/2021
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 4, 13MM
• Device Catalogue Number: 02-012-51-4013
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: Not provided; 10/24/2024
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/23/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2013
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male