MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-51-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, approximately 4 years port op the initial right tka, this 52 y/o male patient was revised due to poly wear and the poly being slightly delaminated.Parts and pieces were removed from patient by the surgeon, he pulled the poly out and irrigated the wound w 3000 cc of antibiotic.There was a 5-15 min surgical delay, no adverse event as a result.Patient was last known to be in stable condition following the event.Device is not returning.
Additional Manufacturer Narrative
(h3) the revision reported may have been due to a combination of orientation of the components, third body wear, and/or patient related conditions which led to wear of the tibial insert.However, this cannot be confirmed because the component was not returned for evaluation and images were not provided.The following sections have corrected information: (d1) brand name: logic tib insert impl crc, sz 4, 9mm.(d4) catalog number: 02-012-51-4009, serial number: (b)(6), expiration date: 28-dec-2023, unique identifier (udi)#: (b)(4).(h4) device manufacture date: 30-dec-2015.(h6) component code: 4755, part/component/sub-assembly term not applicable.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14975712
• Report Number: 1038671-2022-00776
• Device Sequence Number: 5099386
• Product Code: JWH
• UDI-Device Identifier: 10885862230485
• UDI-Public: 10885862230485
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/28/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2023
• Device Model Number: 02-012-51-4009
• Device Catalogue Number: 02-012-51-4009
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male