MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-4009
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that approximately 127 months after a left total knee replacement procedure, the patient has experienced prosthesis wear, osteolysis.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D1- updated.D4: added catalog number, expiration date, serial number, and udi.G4: added 510k number.H4: added device manufacture date.H6: corrected health effect - clinical code, medical device problem code, type of investigation.The reason for the revision reported in incident cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and product information were not provided.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20070671
• Report Number: 1038671-2024-03083
• Device Sequence Number: 8826397
• Product Code: JWH
• UDI-Device Identifier: 10885862173638
• UDI-Public: 10885862173638
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• 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): 11/11/2024

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
• Device Expiration Date: 01/02/2021
• Device Catalogue Number: 02-012-44-4009
• 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: 02/15/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2013
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male