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

Device Problem Fracture (1260)

Patient Problems Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Morrey et al."ulnar component surface finish influenced the outcome of primary coonrad-morrey total elbow arthroplasty." journal title.21:1229-1235.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 fifteen patients underwent elbow arthroplasty revisions due to fracture of the ulnar component one to sixteen years post-operatively.No further information is available.

Manufacturer Narrative

This follow-up report is being filed to correct information.Zimmer biomet became aware of the reported event on january 16, 2017, rather than january 17, 2017 as previously reported.

Event Description

It is reported in a journal article that fifteen patients underwent elbow arthroplasty revisions due to fracture of the ulnar component one to sixteen years post-operatively.No further information is available.An unknown number of these patients also showed radiographic evidence of osteolysis.

• Brand Name: UNKNOWN COONRAD-MORREY SINTERED BEAD POROUS-COATED 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: 6307282
• MDR Text Key: 66715378
• Report Number: 0001822565-2017-00590
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• 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