MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately two years post initial left tka, the 66 y/o female patient had a revision.Patient was complaining since 6 months of original tka of pain, swelling and discomfort.Patient had little inflammatory syndrome but presence of granulum.The pe is heavily worn behind the posterior cam and in the angle of the external femoral condyle.Only patient's insert has been replaced.X-rays and photos received.The device will be return.
Additional Manufacturer Narrative
After further review of additional information received the following sections d9, g3, g6, h2, h3, h6 and h9 have been updated accordingly.(h3) the revision reported was likely the result of joint laxity and/or instability which led to the femoral cam contacting the posterior of the tibial insert spine and subsequent wear.Additionally, it is likely that a contributing factor to the wear seen on the returned tibial insert may have been the 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 IMPLANT PSC INSERT, SZ 1, 13MM
• 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: 14632498
• Report Number: 1038671-2022-00651
• Device Sequence Number: 17621972
• Product Code: JWH
• UDI-Device Identifier: 10885862173416
• UDI-Public: 10885862173416
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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: 05/13/2023
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 13MM
• Device Catalogue Number: 02-012-44-1013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female