MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 4, 9MM, SLOPE +; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT SZ 4, 9MM, SLOPE +
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: holding pin mini sharp point 4 pk (cat# 201-78-15 /serial# (b)(4)).11-4132 stryker sys 6 90x13/21x1.19 (cat# 203-96-42 /serial# (b)(4)).Three peg patella 38mm (cat# 200-02-38 /serial# (b)(4)).Cemented finned tib.Tra sz 4f/4t (cat# 200-04-44 /serial# (b)(4)).Optetrak asy, cr porous femoral, sz 4, left (cat# 232-02-04 /serial# (b)(4)).Cr tibial insert sz 4, 9mm, slope + (cat# 200-64-09 /serial# (b)(4)).Cemented finned tib.Tra sz 4f/4t (cat# 200-04-44 / serial# (b)(4)).Three peg patella 38mm (cat# 200-02-38 / serial# (b)(4)).Optetrak asy, cr porous femoral, sz 4, right (cat# 232-03-04 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the patient presented with pain and instability.The surgeon noted there was severe damage to the poly and there were noticeable damage on the tibial tray.The surgeon had to revise this to a hinge knee.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
(h3) the evaluation noted that revision reported was likely the result of a combination of axial rotation mismatch of the femoral component relative to the tibial insert, the overall posterior slope of the tibial insert, and patient conditions, which allowed for excessive posterior contact, especially medially, and led to severe wear of the polyethylene and tibial tray.The wear of the tibial tray likely resulted in the observed metallosis.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 4, 9MM, SLOPE +
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12170656
• Report Number: 1038671-2021-00340
• Device Sequence Number: 3858028
• Product Code: JWH
• UDI-Device Identifier: 10885862041104
• UDI-Public: 10885862041104
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 05/17/2015
• Device Model Number: CR TIBIAL INSERT SZ 4, 9MM, SLOPE +
• Device Catalogue Number: 200-64-09
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 10/20/2021
• 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
• Patient Age: 60 YR