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

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Osteolysis (2377); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Medical device site infection (4845)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation a patient had a right knee replacement on (b)(6) 2015.Approximately 5 years and 7 months after the initial surgery the patient had a right knee revision on (b)(6) 2021.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H6.Investigation results- there is no device information provided.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.There is no other information available.
Additional Manufacturer Narrative
H11.Additional manufacturer narrative- additional information added.D10.Concomitants: (b)(6) 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.(b)(6) 200-02-41 - three peg patella 41mm.(b)(6) 02-010-03-0350 - logic cr femoral cem, right, sz 5.These devices are used for treatment not diagnosis.There is no additional information available.Pending updated investigation.
Event or Problem Description
Revision op report -the patient was revised to competitor's devices.Diagnosis: - failed right total knee arthroplasty.- right knee prosthetic joint infection.- severe femoral and tibia bone loss after total knee arthroplasty.- right knee stiffness.The tibial polyethylene was removed and the femoral, tibia and patella implants were removed carefully to avoid fractures or major bone loss.The patient had severe femoral and tibia bone loss.Proceed with extensive debridement of purulent and inflamed synovium.The patient is transferred to the recovery room in stable condition after reversal of anesthesia.There is no other information available.
Additional Manufacturer Narrative
Recall number: z-0021-2022.This follow-up report is being submitted to relay additional and/or corrected information.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.Multiple mdr reports were filed for this event, associated reports: 1038671-2024-04666.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, infection and/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 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 CR TIB INSERT SLOPE+, SZ 5, 9MM
• 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 ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17061568
• Report Number: 1038671-2023-01238
• Device Sequence Number: 18287014
• Product Code: JWH
• UDI-Device Identifier: 10885862174581
• UDI-Public: 10885862174581
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/06/2024

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: 09/14/2019
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 02-012-48-5009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 06/08/2023; 08/01/2024; 12/05/2024
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 06/08/2023; 08/08/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2011
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male