MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-11-0350
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 02-022-44-5011 - truliant tib imp psc insert sz 5, 11mm 5758926.02-022-45-5040 - truliant tib fit tray cem sz 5f / 4t 5820426.200-02-38 - three peg patella 38mm 5626403.201-78-82 - collar fixation pin 2pk 40mm, quick release 5788849.201-78-89 - 3" drill bit, mod.Hex 2 pack 6120128.201-78-89 - 3" drill bit, mod.Hex 2 pack 6122086.
Event or Problem Description
As reported, sales rep reached out to manufacture engineer to informed that surgeon did a revision of a femoral component and tibial insert.Also according to sales rep very soon after the knee replacement the patient underwent a same side hip fusion where the hip was fused with internal rotation.The surgeon believe this may have led to complications in the knee joint.Sales rep is sending the tibial insert back and per doctor¿s request for device analysis review.The original date of surgery according to sales rep was (b)(6) 2020.
Additional Manufacturer Narrative
H3: the reason for the knee revision reported is most likely the result of femoral loosening and subsequent third body wear on the tibial insert.The changed kinematics following the reported hip fusion are likely contributing factors to the sequence of events but cannot be confirmed from the available information.
Additional Manufacturer Narrative
D10: concomitant devices: (b)(6), 02-022-45-5040 - truliant tib fit tray cem sz 5f / 4t; (b)(6), 200-02-38 - three peg patella 38mm; (b)(6), 201-78-82 - collar fixation pin 2pk 40mm, quick release; (b)(6), 201-78-89 - 3" drill bit, mod.Hex 2 pack.The reason for the knee revision reported is most likely the result of femoral loosening and subsequent third body wear on the tibial insert.The changed kinematics following the reported hip fusion are likely contributing factors to the sequence of events but cannot be confirmed from the available information.

• Brand Name: EXACTECH
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653 1197
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19757624
• Report Number: 1038671-2024-02410
• Device Sequence Number: 15075951
• Product Code: JWH
• UDI-Device Identifier: 10885862314581
• UDI-Public: 10885862314581
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 10/08/2024

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 Catalogue Number: 02-020-11-0350
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 09/29/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/06/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown