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

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.

• 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 Key: 5846811
• MDR Text Key: 51156648
• Report Number: 0001822565-2016-02707
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• 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

• Date FDA Received: 08/04/2016
• 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
• Date Manufacturer Received: 10/17/2016
• 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 Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR