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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC. DEPUY SHOULDER; PROSTHESIS, SHOULDER Back to Search Results
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.
 
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Brand Name
DEPUY SHOULDER
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC.
MDR Report Key8597011
MDR Text Key144682432
Report NumberMW5086503
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received05/09/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age59 YR
Patient Weight136
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