MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL CEM, LEFT SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-03-0225
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) -2024-00850 d10 concomitant devices (b)(6) - 02-012-49-2509 - logic tibial insert slope ++, sz 2.5, 9 mm (b)(6) - 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 5t (b)(6) - 200-02-35 - three peg patella 35mm (b)(6) - 201-78-15 - holding pin mini sharp point 4 pk (b)(6) - 201-78-81 - 3 trocar, mod.Hex 2pk (b)(6) - 21-78-23 - 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.Manufacturer narrative: the revision reported in was most likely the result of a combination of prosthesis wear secondary to contributions from implant alignment and/or instability of the knee as well as loosening due to mechanical loss of fixation at the cement/implant interface.However, this cannot be confirmed as the devices were not returned for evaluation and the loosening could not be confirmed on the pre-revision radiograph.
Event or Problem Description
It was reported that a 63yo male patient, initial left knee implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2024, approximately 5 years post the initial procedure.The patient was revised due to femur loosening and poly wear.- everything was removed and exchanged to a competitor¿s product.There were no surgical delays or device breakages during the procedure.X-rays were provided.The patient was last known to be in stable condition following the event.No explanted devices are available for analysis.They were disposed of by the hospital.Device images were provided.

• Brand Name: LOGIC CR FEMORAL CEM, LEFT SZ 2.5
• 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 FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20301350
• Report Number: 1038671-2024-03696
• Device Sequence Number: 12982559
• Product Code: JWH
• UDI-Device Identifier: 10885862158000
• UDI-Public: 10885862158000
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• 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
• Report Date (Section B): 09/25/2024

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: 09/11/2018
• Device Catalogue Number: 02-010-03-0225
• 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: 09/18/2024
• Initial Report FDA Received Date: 09/25/2024
• Date Device Manufactured: 09/13/2018
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 79 KG