MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA PS MOD INSRT SZ 4 15MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately five years post initial right tka, this patient is presenting with osteolysis on the medial femoral epicondyle which is currently asymptomatic but surgeon believes it¿s due to poly wear.At the moment the patient is considering their options but surgeon anticipates the poly exchange will occur within the next three months.X-ray received.No other information provided.
Additional Manufacturer Narrative
Concomitant medical products: logic femoral ps cem right sz 4 (cat# 02-010-01-0340 / serial# (b)(4)).Lgc tibial fit tray cem sz 4f / 4t (cat# 02-012-45-4040 / serial# (b)(4)).Three peg patella 41mm (cat# 200-02-41 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Section b5: additional information received indicates that the patient was revised on (b)(6)2022.Per x-ray received what was originally thought to be osteolysis turned out to be stress shielding.H3: the revision reported was likely the result of axial rotation mismatch of the femoral component relative to the tibial insert which led to severe wear of the polyethylene.Additionally, a contributing factor to the severe wear and delamination may have been result of being packaged in a non-conforming vacuum bag for more than five years.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 TIBIA PS MOD INSRT SZ 4 15MM
• 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: 14427287
• Report Number: 1038671-2022-00560
• Device Sequence Number: 6530927
• Product Code: JWH
• UDI-Device Identifier: 10885862001917
• UDI-Public: 10885862001917
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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: 12/17/2018
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 4 15MM
• Device Catalogue Number: 02-012-35-4015
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: THREADED PIN SIZE 2.3 COLLARED 2PK; THREADED PIN SIZE 2.3 COLLARED 2PK; THREADED PIN SIZE 3.0 COLLARLESS 2PK; THREADED PIN SIZE 5.1 COLLARLESS 2PK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown