MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC FEMORAL PS CEM LEFT SZ 2.5
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.Concomitant product(s): logic tibia ps mod insrt sz 2.5 13mm (cat#: 02-012-35-2513 / serial#: (b)(4)).
Event or Problem Description
As reported, the (b)(6) y/o male patient¿s femur was revised due to loosening of the left knee prosthesis.The insert was removed, and the femur was pulled off.The patient has a history of osteoarthritis.The tibia was well fixed.The patient received a logic cc femoral prosthesis and a new insert.The patient revived a size 2 left logic cc femur with a splined press fit stem and new insert.Patient was last known to be in stable condition following the event.The device will return.
Additional Manufacturer Narrative
H3: the evaluation noted that revision reported was likely the result of an insufficient bond between the femoral component and bone which led to aseptic loosening and subsequent prosthesis wear secondary to an increase in cement and bone particles in the joint space.The most probable root cause associated with the reported event of " loosening - femoral" is associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 2.5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11338425
• Report Number: 1038671-2021-00050
• Device Sequence Number: 16358360
• Product Code: JWH
• UDI-Device Identifier: 10885862001139
• UDI-Public: 10885862001139
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 07/05/2017
• Device Model Number: LOGIC FEMORAL PS CEM LEFT SZ 2.5
• Device Catalogue Number: 02-010-01-0225
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 85 YR