MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXEL ELBOW ARTICULATION KIT SIZE; PROSTHESIS, ELBOW

Model Number N/A

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

Patient Problems Bone Fracture(s) (1870); Osteolysis (2377); Osteopenia/ Osteoporosis (2651)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: humeral component plasma sprayed size 4 cat# 00840004410 lot# 62853361, humeral screw kit 2 humeral screws cat# 00840009000 lot# 62810154, ulnar component plasma sprayed size 4 cat# 00840002407 lot# 62764440.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04990, 0001822565 - 2019 - 04991.

Event Description

It was reported that a patient underwent an initial right total elbow arthroplasty.During the 6 month follow up visit, it was incidentally noted on xray review that the patient had a completely nontender and asymptomatic old medial column stress fracture of the humeral epicondyle now healed without intervention.During the 2 year follow up, xray review revealed stress shielding osteolysis on the same humeral epicondyle.No intervention or revision has been planned to date.Patient reports high satisfaction, full rom, and no complaints at each of the follow up visits.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon reassessment of the reported event, the articulation kit was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, the articulation kit was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: NEXEL ELBOW ARTICULATION KIT SIZE
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9368632
• MDR Text Key: 167777473
• Report Number: 0001822565-2019-04992
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

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: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00840009400
• Device Lot Number: 62875488
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 75