MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0260
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D1o: (b)(6), 02-012-45-6050 - lgc tibial fit tray cem sz 6f / 5t; (b)(6), 201-78-15 - holding pin mini sharp point 4 pk; (b)(6), 201-78-81 - 3 trocar, mod.Hex 2pk; (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), a10012 - gps implant kit v2; (b)(6), a10012 - gps implant kit v2.
Event or Problem Description
As reported, approximately 4 years and 2 months post the initial left tka, the patient was revised due to wear on patella and tibial insert, and the femoral component debonded from the cement.Everything was removed and replaced with competitor devices.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening from the cement mantle as reported, or due to inclusion of the polyethylene in the packaging recall.However, the articular surfaces of the explanted tibial insert and patella appear consistent with an implanted devices although damage secondary to contact between the femoral component cam and the posterior aspect of the tibial insert spine is confirmed.Femoral component loosening cannot be confirmed from the provided information 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.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 6
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19826918
• Report Number: 1038671-2024-02520
• Device Sequence Number: 20985798
• Product Code: JWH
• UDI-Device Identifier: 10885862001184
• UDI-Public: 10885862001184
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: 10/01/2024
• Device Catalogue Number: 02-010-01-0260
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2019
• 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: Required Intervention
• Patient Sex: Male