MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK C-M ULNA COMPONENT; PROSTHESIS, ELBOW

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).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: 0001822565-2020-01938.

Event Description

In a journal article published approximately 1 year ago, studying the tea survivorship of arthritic patients under age 55, it was reported that 1 of 19 patients was found to underwent a revision for hinge wear.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Siala, m.Et al.Outcomes of semiconstrained total elbow arthroplasty performed for arthritis in patients under 55 years old.Journal of shoulder and elbow surgery.2019: 1-8.This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h2, h6, h10.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 lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 is available at the time of this report.

• Brand Name: UNK C-M ULNA COMPONENT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10104725
• MDR Text Key: 193014053
• Report Number: 0001822565-2020-01939
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Treatment: UNK C-M HUMERAL COMPONENT CAT#NI LOT#NI; UNK C-M HUMERAL COMPONENT CAT#NI LOT#NI
• Patient Outcome(s): Hospitalization; Required Intervention