MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.Concomitant medical products: optetrak asy,cr cemented femoral, sz 2; cemented finned tib.Tra sz 2f/3t.
Event or Problem Description
As reported, when the patient who had optetrak cr total knee arthroplasty using cr slope++ insert came to the outpatient clinic for regular post-operative examinations, the surgeon observed a suspected metalosis due to severe posterior wear of cr slope++ tibial insert on the x-ray images.In the x-ray findings, metalosis was apparently suspected by the tibial tray breakage/wear due to the impingement with the metallic femoral component that might be occurred after the tibial insert was completely worn out.Patient is scheduled to have revision total knee arthroplasty.The surgeon decided to use other knee system for the revision surgery.The devices are still implanted.Revision surgery is scheduled.
Additional Manufacturer Narrative
(h3) the evaluation noted that revision reported was likely the result of excessive overall posterior tibial slope of the tibial insert, which allowed for excessive posterior contact between the femoral component and the tibial insert, leading to severe posterior wear of the tibial insert.The severe posterior wear of the tibial insert likely allowed for the femoral component to articulate on the posterior aspect of the tibial tray and ultimately result in the reported ¿tibial tray breakage / wear¿ and ¿suspected metalosis.¿ however, this cannot be confirmed as the devices were not returned for evaluation and x-ray images/images of the devices were not provided.The most probable root cause for 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 2, 11MM, SLOPE ++
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11295527
• Report Number: 1038671-2021-00027
• Device Sequence Number: 3500154
• Product Code: JWH
• UDI-Device Identifier: 10885862041227
• UDI-Public: 10885862041227
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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: 09/20/2024
• Device Model Number: CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++
• Device Catalogue Number: 200-72-11
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 03/22/2021
• 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