MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	02-012-49-5013
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561); Joint effusion (4849)
Date of Event	04/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 02-012-51-4013 - logic tib insert impl crc, sz 4, 13mm 2855022 02-010-03-0240 - logic cr femoral cem, left, sz 4 2618033 02-010-03-0350 - logic cr femoral cem, right, sz 5 2241853 02-012-45-4050 - lgc tibial fit tray cem sz 4f / 5t 2965312 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t 3691458 200-02-38 - three peg patella 38mm 3602242 200-02-38 - three peg patella 38mm 3602296 201-78-15 - holding pin mini sharp point 4 pk 2950666 201-78-82 - collar fixation pin 2pk 40mm, quick release 3767188 201-78-89 - 3" drill bit, mod.Hex 2 pack 3686417 201-78-89 - 3" drill bit, mod.Hex 2 pack 3830134 pending investigation.
Event or Problem Description
As reported via legal documentation the 59 y/o male patient had a right knee replacement on (b)(6)2015.Approximately 7 years and 2 months after the initial procedure the patient had a right 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 right knee arthroplasty due to polyethylene wear and flexion instability, femoral component found to be the debonded from the cement."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.There is no cement attached to the femoral component.The remaining cement was removed piecemeal with an osteotome, taking care to avoid damaging the remaining bone stock.The patient was roused from anesthesia, having tolerated the procedure well without complication.He was brought to pacu in stable condition.".
Additional Manufacturer Narrative
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 CR TIB INSERT SLOPE++, SZ 5, 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: geoff gannon ; 3523771140
• MDR Report Key: 17334502
• Report Number: 1038671-2023-01679
• Device Sequence Number: 17974746
• Product Code: JWH
• UDI-Device Identifier: 10885862174635
• UDI-Public: 10885862174635
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• 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
• 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: 11/09/2019
• Device Model Number: 02-012-49-5013
• Device Catalogue Number: 02-012-49-5013
• 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: 10/24/2024
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2011
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male