MAUDE Adverse Event Report: EXACTECH, INC. LOGIC PS CEMENTED FEMORAL COMPONENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC PS CEMENTED FEMORAL COMPONENT
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products logic stem ext 14mm x 160mm (cat# 02-012-60-1416 / serial# (b)(4)).Logic cc tib insert size 4, 19mm (cat# 02-012-65-4019 / serial# (b)(4)).Logic post.Aug.Block size 4, 5mm (cat# 02-010-06-0541 / serial# (b)(4)).Cc distal fem augment sz 4, 10mm (cat# 208-06-04 / serial# (b)(4)).Cc distal fem augment sz 4, 10mm (cat# 208-06-04 / serial# (b)(4)).Cc femoral aug screw 15mm (cat# 208-10-15 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, this (b)(6) male's case was booked as a femoral revision.Upon removal it was found to have a loose body, possibly a cap from the tibial tray augment screw hole.Revised to trulient cck with stems up, and down augments, and antibiotic bead kit.Patient was last known to be in stable condition following the event.The devices are not available for evaluation due to hospital policy.
Additional Manufacturer Narrative
After further review of additional information received the following sections d1, d4, g3, g7 and h2 have been updated accordingly.Additional information, including the product investigation, will be submitted within 30 days of receipt corrected section(s): section d1: logic cc femoral size 4, left.Section d4: model number, catalog number, serial number, unique identifier (udi)#.Section d10: concomitant medical products.Section g4: pma/510(k)number.(d4) device information provided is not correct.Investigation still ongoing.(d10) concomitant medical products: logic tibial insert.Logic tibial tray.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of femoral loosening.However, the revised components were not returned for evaluation and not enough information was provided to determine the cause of the possible loosening or the origin/cause of the ¿loose body¿ reportedly found in the joint space.The most probable root cause associated with the reported event of "loosening" is an adverse event appears to have occurred but there is not yet enough information available to classify the device problem.

• Brand Name: LOGIC PS CEMENTED FEMORAL COMPONENT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12484289
• Report Number: 1038671-2021-00485
• Device Sequence Number: 3891479
• Product Code: JWH
• UDI-Device Identifier: 10885862265678
• UDI-Public: 10885862265678
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2022

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 Model Number: LOGIC PS CEMENTED FEMORAL COMPONENT
• 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: 08/30/2021
• Supplement Date Received by Manufacturer: 10/25/2021; 12/14/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 11/22/2021; 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Disability; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male