MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN COONRAD-MORREY IMPLANT; ELBOW PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

Mansat et al."total elbow arthroplasty for acute distal humeral fractures in patients over 65 years old - results of a multicenter study in 87 patients." orthopaedics & traumatology : surgery & research (2013) 99:779-784.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.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.The article was written by p.Mansat, h.Nouaille degorce, n.Bonnevialle, h.Demezon, t.Fabre and sofcot involving (b)(6).

Event Description

It is reported in a journal article that five patients experienced hematoma six to one-hundred-six months following elbow arthroplasty.No further information is available.

• Brand Name: UNKNOWN COONRAD-MORREY IMPLANT
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6315876
• MDR Text Key: 67103751
• Report Number: 0001822565-2017-00646
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2017

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 02/09/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other