MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CC TIBIAL INSERT SZ 4, 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/30/2021
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
During office visit, surgeon did a condylar constrained liner exchange on a revision he done in 2003, on (b)(6) 2021.This was a liner exchange of a size 4/13 mm condylar constrained insert.The liner had medial wear.Also the spine stiffening screw had sheared off at the threaded junction of the screw.Surgeon was unable to retrieve the rest of the screw that was locked into the stem and tibial tray.This did not affect the insertion of a new condylar constrained liner, but was unable to place a new spine stiffening screw in due to the broken piece still in there.There was no breakage to device.There was no surgical delay or prolongation.Patient was last known to be in stable condition following the event.The device will be return.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of prosthesis wear, which may have been due to the alignment between the femoral and tibial components, third body wear, and/or patient-related conditions, and fracturing of the spine stiffening screw after being implanted for approximately 18 years.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: CC TIBIAL INSERT SZ 4, 13MM
• 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: 13057292
• Report Number: 1038671-2021-00719
• Device Sequence Number: 16500691
• Product Code: JWH
• UDI-Device Identifier: 10885862054340
• UDI-Public: 10885862054340
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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 Model Number: CC TIBIAL INSERT SZ 4, 13MM
• Device Catalogue Number: 208-24-13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 78 YR
• Patient Sex: Male