MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 10/12/2023

Event Type  Injury  

Event Description

As reported, approximately 11 years post op initial tka, this 74 y/o female patient was revised.The tibial polyethylene was extensively gone with a central split down the center of the medial compartment of the polyethylene.The patellar polyethylene insert was loose in the joint.The knee had extensive synovitis as as result of large amounts of polyethylene wear throughout the joint.Everything was removed and replaced by competitor device.Patient was last known to be in stable condition following the event.Images and x-rays were not provided.Product not returning: disposed of at hospital.

Manufacturer Narrative

Section h10: (h3) pending evaluation (d10) concomitant device(s): optetrak ps femoral cem, optetrak cem trap tib tray, three peg patella.

Manufacturer Narrative

Section h10: (h3) the revision reported may have been the result of patella loosening and prosthesis wear.The aseptic (non-infected) loosening may have been the result of a deterioration of the bond between the patella component and the bone from over 10 years of use.The tibial insert wear may have been due to malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the devices were not returned for evaluation and images of the explanted devices and pre-revision radiographs were not provided.Section h11: *the following sections have corrected information: (d2a) product code: jwh (d2b) common device name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.

• Brand Name: PS TIBIAL INSERT
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18083133
• MDR Text Key: 327487023
• Report Number: 1038671-2023-02695
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• 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: 01/15/2024
• 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
• Treatment: SEE H10
• Patient Age: 74 YR
• Patient Sex: Female