MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 2 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	OPTETRAK HI-FLEX TIBIAL INSERT SZ 2 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/05/2021
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 8 yrs postop the initial l tka, the surgeon completed a l knee scope on this female patient previously and noticed severe delamination of the poly.He then scheduled the patient for a poly swap where he removed the current poly and put in a new insert.The patient wanted the most minimal fix, meaning switching out the old insert for a new insert.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
After further review of additional information received the following sections b5, g3, g7 and h2 have been updated accordingly.Section b5: additional information received indicates that the patient symptoms were knee pain, that is also why the surgeon did the scope.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g7, h2, h3 and h6 have been updated accordingly.(h3) the evaluation noted that revision reported was likely the result of a combination of rotational mismatch between the femoral and tibial components (femoral component externally rotated and/or tibial components internally rotated) and third body wear, which resulted in polyethylene wear and severe delamination on the tibial insert.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: OPTETRAK HI-FLEX TIBIAL INSERT SZ 2 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11877855
• Report Number: 1038671-2021-00247
• Device Sequence Number: 13728076
• Product Code: JWH
• UDI-Device Identifier: 10885862063977
• UDI-Public: 10885862063977
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2021

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: 01/26/2017
• Device Model Number: OPTETRAK HI-FLEX TIBIAL INSERT SZ 2 13MM
• Device Catalogue Number: 244-22-13
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 06/08/2021; 07/19/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/29/2021; 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability