MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULATION KIT SIZE 5/6 1 AXLE PIN, 1 HUMERAL BEARING A; PROSTHESIS, ELBOW

Catalog Number 00840009500

Device Problem Positioning Failure (1158)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that there was a problem with the assembly between the humeral bearing and the hole of the humeral component there was a surgical delay of 30 minutes.Another component was used to complete the procedure.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified that the peg on the bearing is compressed, damage too severe for dimensional analysis.Device history record (dhr) was reviewed and no discrepancies were found.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 additional event information is available at the time of this report.

• Brand Name: ARTICULATION KIT SIZE 5/6 1 AXLE PIN, 1 HUMERAL BEARING A
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10906641
• MDR Text Key: 218659111
• Report Number: 0001822565-2020-03933
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 00840009500
• Device Lot Number: 64136711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 03/25/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1