MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 1 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTE

Model Number	LOGIC TIBIA PS MOD INSRT SZ 1 9MM
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2021-00198 and 1038671-2021-00199.
Event or Problem Description
As reported, during the initial implant for this (b)(6) year old female patient, the polyethylene tibial insert size1, 9mm two (2) pieces were cracked when the surgeon was inserting the tibial insert driver (before impaction).The crack was found damaged in the area in central mushroom hole, peripheral rim and backside of articular surface.The operation time delayed about one hour.The devices will be returned.
Additional Manufacturer Narrative
Section d1: brand name.Section d4: model number, catalog number, manufactured date & unique identifier (udi)#.Section g4: pma/510(k) number.Section h4: expiration date.
Additional Manufacturer Narrative
After further review of additional information received.(h3) the evaluation noted that revision reported was likely the result of seating difficulties from not properly aligning the posterior undercuts of the tibial inserts with the mating geometry of the tibial tray, which prohibited the components from fully seating and led to deformation of the polyethylene.The most probable root cause associated with the reported event of "crack" is associated with assembling or seating a polyethylene component during implantation.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2021-00198 and 1038671-2021-00199.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 1 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11733796
• Report Number: 1038671-2021-00199
• Device Sequence Number: 3193093
• Product Code: JWH
• UDI-Device Identifier: 10885862001795
• UDI-Public: 10885862001795
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/26/2022
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 1 9MM
• Device Catalogue Number: 02-012-35-1009
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 04/20/2021; 05/25/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 05/15/2021; 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR