MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 2, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	208-22-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal that on (b)(6) 2011, a female patient underwent a left tkr with an optetrak tibial insert.Approximately april the patient noticed a ¿squeak¿ in her right knee, and she began experiencing intermittent dull pain and aching in that joint.Her symptoms progressively worsened, but the pain remained moderate and was treatable with anti-inflammatories.In (b)(6) 2019, the patient fell at work, causing increased pain, stiffness, and weakness in her right knee.On (b)(6) 2019, the patient underwent revision of her right optetrak device.Upon explantation of the optetrak device, the surgeon observed that there was a ¿tremendous amount¿ of synovitic material and inflammation consistent with polyethylene wear.The components of the optetrak device were loose, and some were removable without the use of any instruments.No additional information.
Additional Manufacturer Narrative
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, however, it may be related to the post traumatic event that the patient had when they fell.It is known that falls to replaced joints are detrimental to the patient and the replacement devices.Devices that are loosened may cause undue wear and early failure.200-02-32 - three peg patella 32mm, (b)(4); 204-04-22 - trapezoid tibial tray sz 1f/2t, 2f/2t, (b)(4); 204-32-01 - fluted stem extension 11l x 12 mm, (b)(4); 210-01-02 - nmc femoral sz 2, (b)(4).Correction/removal number: z-0019-2022.

• Brand Name: CC TIBIAL INSERT SZ 2, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15912334
• Report Number: 1038671-2022-01559
• Device Sequence Number: 11385909
• Product Code: JWH
• UDI-Device Identifier: 10885862054197
• UDI-Public: 10885862054197
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/03/2022

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: 09/27/2015
• Device Model Number: 208-22-15
• Device Catalogue Number: 208-22-15
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female