MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 6, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-6009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	08/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): (b)(6) 02-012-45-6050 - lgc tibial fit tray cem sz 6f / 5t.(b)(6) 200-02-41 - three peg patella 41mm.(b)(6) 201-78-15 - holding pin mini sharp point 4 pk.(b)(6) 521-78-23 - threaded pin size 2.3 collared.(b)(6) 521-78-23 - threaded pin size 2.3 collared.(b)(6) 521-78-23 - threaded pin size 2.3 collared.(b)(6) 521-78-32 - threaded pin size 3.0 collarless.(b)(6) 521-78-32 - threaded pin size 3.0 collarless.(b)(6) 521-78-36 - threaded pin size 5.1 collarless.(b)(6) a10012 - gps implant kit v2.
Event or Problem Description
It was reported that this male patient's left knee was revised due to suspected implant loosening in femur and poly wear/ lysis.Everything was removed.Patient was not revised to exactech devices.Patient was last known to be in stable condition following the event.Product not returning: discarded at the hospital.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of femoral loosening and prosthesis wear.The suspected loosening may have been due to an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the femoral component.The prosthesis wear may have been due to increased loading to the posterior lateral aspect of the insert.However, this cannot 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 radiographs or relevant clinical information was provided.Additionally, a contributing factor to the prosthesis wear may have been the insert being packaging in a non-conforming bag for more than 5 years.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 6, 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20157408
• Report Number: 1038671-2024-03336
• Device Sequence Number: 4236544
• Product Code: JWH
• UDI-Device Identifier: 10885862174642
• UDI-Public: 10885862174642
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2022
• Device Catalogue Number: 02-012-47-6009
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2014
• 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
• Patient Sex: Male