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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Mckee et al."a multicenter, prospective, randomized, controlled trial of open reduction internal fixation versus total elbow arthroplasty for displaced intra-articular distal humeral fractures in elderly patients." j shoulder elbow surg (2009).18:3-12.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.(b)(6).

Event Description

It is reported in a journal article that one patient underwent a two-stage elbow arthroplasty revision due to progressive ulnar radiolucency, an early wound problem with persistent drainage and a deep infection that developed nine months following elbow arthroplasty.No further information is available.

• Brand Name: UNKNOWN COONRAD-MORREY ULNAR COMPONENT
• 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: 6325443
• MDR Text Key: 67235597
• Report Number: 0001822565-2017-00700
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2017
• 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): Hospitalization; Required Intervention