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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Ossification (1428); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

Morrey et al."is coonrad-morrey total elbow arthroplasty a viable option for treatment of distal humeral nonunions in the elderly?" journal title.49(4):354-360.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 ali ersen, mehmet demirhan, ata can atalar, teoman atici and mehmet kapicioglu involving the hospitals istanbul university istanbul faculty of medicine, koc university school of medicine and uludag university faculty of medicine, turkey.

Event Description

It is reported in a journal article that one patient is scheduled to undergo elbow arthroplasty revision due to loosening of the humeral component.The patient also had flexion contracture of more than 20 degrees due to heterotopic ossification.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.

• Brand Name: UNKNOWN COONRAD-MORREY HUMERAL 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: 6309636
• MDR Text Key: 66760408
• Report Number: 0001822565-2017-00604
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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,Followup
• Report Date: 02/06/2017

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?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2017
• 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): Required Intervention
• Patient Age: 64 YR