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

Catalog Number	208-22-15
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/30/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a right knee arthroplasty on (b)(6) 2014, with no revision surgery reported.There was no other patient/medical information provided.No x-rays or images were provided.There is no other information available.
Additional Manufacturer Narrative
Pending investigation.There is no other information provided.
Additional Manufacturer Narrative
D4: added catalog number, expiration date, serial number, and udi d10: (b)(6) 204-04-21 - trapezoid tibial tray sz 1f/1t, 2f/1t.(b)(6) 02-012-35-2509 - logic tibia ps mod insrt sz 2.5 9mm.(b)(6) 204-34-12 - fluted stem extension 120l x 14 mm.(b)(6) 02-010-01-0225 - logic femoral ps cem left sz 2.5.(b)(6) 200-02-32 - three peg patella 32mm.(b)(6) 208-09-05 - cc stem ext adaptor 5 degree.(b)(6) 200-02-32 - three peg patella 32mm.(b)(6) 02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t.(b)(6) 204-30-12 - stem extension 120l x10 mm.(b)(6) 208-01-02 - cc femoral sz 2.(b)(6) 204-34-02 - fluted stem extension 25l x 14 mm.(b)(6) 204-70-00 - tibial stem ext.Screw.G3: added 510k number.H4: added device manufacture date.H6: corrected health effect - clinical code, health effect - impact code, component code, type of investigation, investigation findings, and investigation conclusions.Manufacturer narrative updated: the reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or inclusion of the polyethylene in the packaging recall.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: OPTETRAK TIBIAL INSERT
• 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 19347430
• Report Number: 1038671-2024-01332
• Device Sequence Number: 6519748
• 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: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: 12/08/2018
• Device Catalogue Number: 208-22-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2013
• 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: SEE H11.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown