MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; PS TIBIAL INSERTS SZ 4, 11MM

Model Number PS CEMENTED FEMORAL SZ 4

Device Problems Degraded (1153); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported by united kingdom national joint registry (uknjr), this (b)(6) y/o, 177 cm, (b)(6) kg (bmi=31), male patient underwent primary total prosthetic replacement using cement of the right knee via medial parapatellar approach on (b)(6) 2010.The indication for the index procedure was osteoarthritis.The patient was implanted with a optetrak knee system - cemented posterior stabilised (ps) femoral component - size 4 (catalog 204-01-04, serial (b)(4)), optetrak knee system - cemented finned tibial tray - size 4f/4t (catalog 200-04-44, serial (b)(4)), optetrak knee system - posterior stabilised (ps) tibial insert - size 4 - 11mm (catalog 204-24-11, serial (b)(4)), optetrak knee system - three pegs patella - diameter 32mm (catalog 200-02-32, serial (b)(4)) and heraeus medical antibiotic loaded high viscosity bone cement (catalog 66017569, serial (b)(4)).On (b)(6) 2016, approximately 73 months post implantation, the patient underwent revision due to aseptic loosening femur; aseptic loosening tibia; malalignment; wear of polyethylene component.The exactech were removed and replaced.

Manufacturer Narrative

(h3) the evaluation noted that revision reported was likely the result of a combination of prosthesis wear and aseptic loosening between the tibial and femoral components and the bone.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear or prosthesis wear may have contributed to particle-induced osteolysis.However, the contribution of loosening and prosthesis wear to the sequence of events cannot be determined as the devices were not available for evaluation.This submission represents 1 of 163 events identified via active surveillance activities utilizing data form the united kingdom national joint registry (uknjr).Follow-ups for additional information cannot be performed for this complaint as the information was submitted as complete by the registry; there is no identification of facilities or surgeons.All available information about the event and/or patient has been provided and it is not possible to obtain any of the devices.

Event Description

As reported by united kingdom national joint registry (uknjr), this 63 y/o, 177 cm, 97 kg (bmi=31), male patient underwent primary total prosthetic replacement using cement of the right knee via medial parapatellar approach on (b)(6) 2010.The indication for the index procedure was osteoarthritis.On (b)(6) 2016, approximately 73 months post implantation, the patient underwent revision due to aseptic loosening of the femur and tibia, patient conditions (malalignment), and wear of polyethylene component.Follow-ups for additional information cannot be performed for this complaint, information was submitted as complete by the united kingdom national joint registry (uknjr); there is no identification of facilities or surgeons.All available information about the event and/or patient has been provided.These devices are used for treatment not diagnosis.

• Brand Name: OPTETRAK
• Type of Device: PS TIBIAL INSERTS SZ 4, 11MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9711289
• MDR Text Key: 192659570
• Report Number: 1038671-2020-00165
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862047595
• UDI-Public: 10885862047595
• Combination Product (y/n): N
• PMA/PMN Number: K933610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,study
• Type of Report: Initial,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2016
• Device Model Number: PS CEMENTED FEMORAL SZ 4
• Device Catalogue Number: 204-24-11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 97