MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC KNEE COMPONENTS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-022-35-2011
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal department, approximately 3 years post op the initial tka, this female patient was revised.Reason was not reported.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
Section h10: (d10) concomitant device(s): 02-020-11-0320 - truliant ps cem fem ps cem right sz 2 5155581, 02-022-45-2020 - truliant tib fit tray cem sz 2f / 2t 5248473, 200-02-29 - three peg patella 29mm 5444754, 201-78-15 - holding pin mini sharp point 4 pk 5429154, 203-96-64 - sawblades ez1913.M62 90x19, 1.27mm strkr5/6/7 276372, 521-78-23 - threaded pin size 2.3 collared 2pk s004088, 521-78-32 - threaded pin size 3.0 collarless 2pk s004308 (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; no reason for revision was given.

• Brand Name: OPTETRAK LOGIC KNEE COMPONENTS
• 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: 14944762
• Report Number: 1038671-2022-00768
• Device Sequence Number: 6230975
• Product Code: JWH
• UDI-Device Identifier: 10885862304087
• UDI-Public: 10885862304087
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2025
• Device Model Number: 02-022-35-2011
• Device Catalogue Number: 02-022-35-2011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2017
• 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 Sex: Female