MAUDE Adverse Event Report: TORNIER INC. PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number DWD003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Weakness (2145); Tingling (2171); Numbness (2415)

Event Type  Injury  

Event Description

Pain is traveling and is so severe at times.All into neck and down arm.Surgery in 2016 got better but 6 months ago, my arm is much more painful.I have 105 + 2 lot of mobility in it.Can't afford to go to dr and checked.I am on (b)(6).Was doing really good on healing.6 months ago started getting weaker.The pain is all the way into neck and my hand is numb and tingling.Elbow pain.Can't afford to go to doctor.

• Brand Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER INC.
• MDR Report Key: 10837559
• MDR Text Key: 216409587
• Report Number: MW5097858
• Device Sequence Number: 1
• Product Code: KWS
• 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: 11/10/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DWD003
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 57 YR
• Patient Weight: 90