MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER EXTREMEITY; ELBOW PROSTHESIS

Device Problem Biocompatibility (2886)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It was reported that a male patient underwent a left total elbow arthroplasty.The patient will undergo revision, due to disease progression on the ulna side.

Manufacturer Narrative

Information has been received and it has been found the experience reported is not alleging a deficiency against any of zimmer biomet's products.The reported product did not cause or contribute to the event.Zimmer considers this investigation closed.

• Brand Name: UNKNOWN ZIMMER EXTREMEITY
• Type of Device: ELBOW 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: 5825769
• MDR Text Key: 50535779
• Report Number: 0001822565-2016-02586
• Device Sequence Number: 1
• Product Code: JDC
• 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: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other; Required Intervention