MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC. DEPUY SHOULDER; PROSTHESIS, SHOULDER

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Weakness (2145)

Event Date 05/21/2015

Event Type  Injury  

Event Description

I had a total replacement shoulder done in (b)(6) 2015.It never seemed like it was working right; after about 6 months or so it felt like it wanted to fall out of socket and weakness in shoulders.Told drs, they keep saying give it time and it will never be the same as previous shoulders; had to have revision in shoulder (b)(6) 2018.Had shoulder replacement on (b)(6) 2015.Had trouble with it.Ever since then had a 2nd replacement; should be done on same shoulder.On (b)(6) 2018, was told that my shoulder failed due to loose glenoid component with loose glenoid and that caused me much pain over the years after last surgery.

• Brand Name: DEPUY SHOULDER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC.
• MDR Report Key: 8597011
• MDR Text Key: 144682432
• Report Number: MW5086503
• Device Sequence Number: 1
• Product Code: KWS
• 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: 04/14/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 136