MAUDE Adverse Event Report: TORNIER, INC PYROCARBON HUMERAL HEAD; PROSTHESIS, SHOULDER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Date 10/20/2018

Event Type  Injury  

Event Description

Dr (b)(6) at (b)(6) hosp in (b)(6), solicited me to volunteer for a clinical trial to determine if a tornier corp pyrocarbon humeral head can replace a traditional shoulder replacement with a metal humeral head and a rebuilt glenoid socket.He was not forthright in explaining that a primary purpose of this clinical trial is to determine if a pyrocarbon humeral head can avoid the expensive and short-lived rebuilding of the glenoid cavity to accommodate a metal humeral head.The ide study protocol is entitled (b)(6) study ((b)(6)).The investigational device is called the aequalis pyrocarbon humeral head.Due to the age-related, misshaped condition of my glenoid cavity, as well as inadequate cartilage, it was the opinion of dr (b)(6) at (b)(6) hosp in (b)(6) that i was not a candidate for this clinical trial.He wanted to do the surgery on me using a traditional metal humeral head.However, dr (b)(6) explained to me that dr (b)(6) would not know whether i was a candidate for this clinical trial because he did not attend the (b)(6) clinical trial conference.He advised the pyrocarbon humeral head would have at least twice the life span of a metal humeral head and would not require glenoid resurfacing.That did not prove to be the case in my situation and i want to make sure if the device does get fda approval that they qualify the approval as being limited to individuals with uncompromised glenoid sockets.Otherwise, like me, it may not fit, will constantly shift, slide, allow limited motion and result in further damage to the shoulder area.I had this surgery almost two years ago and now am in almost constant pain.Last year dr (b)(6) told me he would remove the pyrocarbon device, when i could no longer bear the expected pain.He said he would replace it with a metal humeral head and rebuild my glenoid socket.Now with damage caused to my glenoid socket by the pyrocarbon humeral head he is reluctant to take out the experimental device.Dr (b)(6) was right, i was not a suitable candidate for this clinical trial and they should not have used me for this study.

• Brand Name: PYROCARBON HUMERAL HEAD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): TORNIER, INC
• MDR Report Key: 8099838
• MDR Text Key: 128393679
• Report Number: MW5081549
• Device Sequence Number: 0
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 93