MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 5, 13MM, SLOPE ++; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT SZ 5, 13MM, SLOPE ++
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/01/2022
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 nine years post initial tka, this 70 y/o male patient had a revision of a cr tibial poly insert.Knee was opened and debrided and washed out, cr tibial poly 13mm ++ was explanted and new poly 15mm neutral insert was impacted into tibial tray.Knee was closed.There was no breakage to device.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays received.The device is not available for evaluation due to hospital policy.
Additional Manufacturer Narrative
After further review of additional information received the following sections b5, g3, g6, h2 and h6 have been updated accordingly.Section b5: additional information received indicates that patient was having pain and could hear metal on metal sound during gait.There was evidence of poly wear.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received.(h3) the revision reported was likely the result of implanting a slope ++ insert with a posteriorly inclined tibial tray, which may have led to excessive posterior slope and subsequent femoral articulation on the posterior edge of the insert and tibial tray.However, this cannot be confirmed because the component was not available for evaluation and no x-rays were provided.The reported ¿metal-on-metal sound¿ was likely the result of contact between the femoral component and the tibial tray, which generated metal debris and caused the dark discoloration of the insert observed in the provided images.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: CR TIBIAL INSERT SZ 5, 13MM, SLOPE ++
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13578282
• Report Number: 1038671-2022-00211
• Device Sequence Number: 11930527
• Product Code: JWH
• UDI-Device Identifier: 10885862041340
• UDI-Public: 10885862041340
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2013
• Device Model Number: CR TIBIAL INSERT SZ 5, 13MM, SLOPE ++
• Device Catalogue Number: 200-75-13
• 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: 02/03/2022
• Supplement Date Received by Manufacturer: 02/23/2022; 07/12/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/15/2022; 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2008
• 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 Age: 70 YR
• Patient Sex: Male