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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.

Event Description

A journal article was recently retrieved from european journal of orthopaedic surgery & traumatology (2019) that reported a retrospective study from (b)(6).The article examine the early clinical and radiological outcome after total elbow arthroplasty (tea), which was implanted from a digastric olecranon osteotomy approach.The study reviewed twenty-two patients treated with coonrad-morrey tea implants.Study consisted of two men and twenty women.The indication for revision was due to fracture in twenty patients, and due to rheumatoid arthritis in 2 patients.The study population had a mean age of 80 years at time of surgery (range 50-96).The mean length of follow-up was for 30 months (range 6-132).The study reported one patient had a traumatic peri-prosthetic fracture of the humerus at 6 months that was treated by graft and anterior plate with a favorable course.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN COONRAD-MOREY ELBOW HUMERAL COMPONENT
• Type of Device: ELBOW, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10127530
• MDR Text Key: 194621593
• Report Number: 0001822565-2020-02011
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention