MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 9 MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 8 yrs postop the initial implant, this (b)(6) male patient presented complaining of pain.The tibia and femur components both were loose.Cr poly was also worn.Knee revised to exactech cck.Patient was last known to be in stable condition following the event.The device will not be returned for analysis due to hospital keep devices per hospital policy.
Additional Manufacturer Narrative
Concomitant medical products: logic tibial fit tray cem sz 2.5f/3.5t (cat# 02-012-45-2535 / serial# :(b)(4)).Logic cr femoral cem rt sz 2.5 (cat# 02-010-03-0325 / serial#:(b)(4) ).Three peg patella 38mm (cat# 200-02-38 / serial#: (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the combination of loosening of the femoral component and tibial tray and prosthesis wear, which led to pain.The wear was likely the result of both the slope ++ tibial insert and the positioning of the femoral components relative to the tibial components which allowed for excessive posterior contact between the femoral component and the tibial insert, especially medially, and led to the reported wear of the polyethylene.The loosening was likely the result of an insufficient bond between the implants and the bone.However, this cannot be confirmed as the devices were not returned for evaluation and pre-revision x-rays were not provided.The most probable root cause associated with the reported event of "loosening¿ 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.Furthermore, the most probable root cause associated with the reported event of "prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 9 MM
• 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: 12909919
• Report Number: 1038671-2021-00649
• Device Sequence Number: 5085703
• Product Code: JWH
• UDI-Device Identifier: 10885862159212
• UDI-Public: 10885862159212
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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 Expiration Date: 08/11/2019
• Device Model Number: LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 9 MM
• Device Catalogue Number: 02-012-49-2509
• 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: 11/14/2021
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2011
• 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 Age: 72 YR
• Patient Sex: Male