MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT SZ4, 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: optetrak asy,cr cemented femoral, sz 4 (cat# 230-03-04 / serial# (b)(4)).Cemented finned tib.Tra sz 4f/4t (cat# 200-04-44 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately nine years post right tka, during removal/withdrawal, an (b)(6) male patient had signs of poly wear and was taken to surgery for poly exchange.The poly was removed, femur and tibia were both checked and found to be loose.The patient was revised with a truliant cc knee system.Patient was last known to be in stable condition following the event.There was no breakage of the device.There was no surgical delay/prolongation.The devices will be return.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of both prosthesis wear and loosening of the femoral and tibial components.The prosthesis wear was likely the combination of malalignment between the femoral and tibial components, third body wear, and patient-related conditions.The aseptic (non-infected) femoral and tibial loosening was likely the result of an insufficient bond between the implants and the bones.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.Furthermore, the most probable root cause associated with the reported event of "looseining ¿ femoral¿ is associated with weakened integration of the femoral component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: CR TIBIAL INSERT SZ4, 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: 13182114
• Report Number: 1038671-2022-00011
• Device Sequence Number: 17157546
• Product Code: JWH
• UDI-Device Identifier: 10885862040312
• UDI-Public: 10885862040312
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 06/06/2022

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: 05/05/2016
• Device Model Number: CR TIBIAL INSERT SZ4, 13MM
• Device Catalogue Number: 200-24-13
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2008
• 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: 84 YR
• Patient Sex: Male