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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER HUMERAL STEM; SHOULDER PROSTHESIS

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ZIMMER, INC. UNKNOWN ZIMMER HUMERAL STEM; SHOULDER PROSTHESIS Back to Search Results
Device Problems Failure To Adhere Or Bond (1031); Material Deformation (2976)
Patient Problems Pain (1994); Arthralgia (2355); Limited Mobility Of The Implanted Joint (2671)
Event Date 06/27/2016
Event Type  Injury  
Manufacturer Narrative
This report will be amended when our investigation is complete.
 
Event Description
It was reported that a male patient was experiencing persistent pain in the right shoulder joint, osteoarthrosis, and instability.Patient x-rays confirmed dislocation.The patient underwent total right reverse shoulder arthroplasty due to dislocation of the reverse prosthesis.During revision surgery, the polyethylene component was noted to be loose sitting within the stem and had a large divot of defect within it.
 
Manufacturer Narrative
This report is being amended to reflect changes.No device or photos were received, therefore the condition of the device is unknown.Device history records cannot be reviewed since the lot number is unknown.This device is used for treatment.Product history search cannot be completed since the lot number is unknown.Surgical notes were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definite root cause cannot be determined with the information provided.
 
Manufacturer Narrative
The root cause remains undetermined.
 
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Brand Name
UNKNOWN ZIMMER HUMERAL STEM
Type of Device
SHOULDER PROSTHESIS
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
carrie schneider
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key5846811
MDR Text Key51156648
Report Number0001822565-2016-02707
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 07/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/12/2016
Initial Date FDA Received08/04/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received10/13/2016
10/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
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