MAUDE Adverse Event Report: ZIMMER INC. REVERSE SHOULDER SYSTEM; PROSTHESIS, SHOULDER

Lot Number MULTIPLE

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

Patient Problems Myocardial Infarction (1969); Pain (1994); Distress (2329); Discomfort (2330); Sleep Dysfunction (2517)

Event Date 05/01/2017

Event Type  Injury  

Event Description

Pain radiating from upper arm, across shoulder joint, into upper chest, throat and neck area.Pain and severe discomfort occurs nightly while sleeping, causing wakefulness, and distress.Duration 15-20 minutes, with subsidence only after arising to vertical position and extending shoulders distally, and attempting deep inhalation breathing (5 minute duration).Symptoms continue multiple times over next few hours.Symptoms occur less frequently but, do not subside for a few hours.Problems seem to abate during waking hours while engaging non-stressful daily activities.After my total reverse shoulder implant, i have a heart attack (subsequent stent implants), however doctor says there's no heart damage.Occurred again.

• Brand Name: REVERSE SHOULDER SYSTEM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER INC.; warsaw IN
• MDR Report Key: 6800145
• MDR Text Key: 82992060
• Report Number: MW5071612
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: MULTIPLE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 64 YR
• Patient Weight: 91