MAUDE Adverse Event Report: EXACTECH, INC. KNEE COMPONENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/20/2022

Event Type  Injury  

Event Description

It was reported via a legal notification, that a 77 yo male patient, who had an initial left knee implanted, date unknown, underwent a revision procedure on (b)(6) 2022, due to a failed left total knee replacement refractory to conservative management.Imaging was consistent with failed left knee arthroplasty.Operative notes indicate the femoral implant was grossly loose and manually removed with minimal bone loss.The tibia was removed with minimal bone loss.The devices were replaced with a competitors products.The patient was transferred to the recovery room in stable condition.No device return anticipated due to this being a legal case.No further information.

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

H10.Updated/additional information - d1, d4 (model no.- na and lot no.- na), d5, g3.H6.Investigation results - the revisions reported was likely the result of an insufficient bond between the femoral component and the bone and/or patient related conditions, which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not returned for evaluation, and no images or radiographs were provided.These devices are used for treatment not diagnosis.No other information available.

• Brand Name: KNEE COMPONENT
• Type of Device: 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: michael crader ; 3523771140
• MDR Report Key: 16224457
• MDR Text Key: 307907740
• Report Number: 1038671-2022-01148
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male