MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL ASSEMBLY; ELBOW, ARTHROPLASTY

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign country: (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.Not returned to manufacturer.

Event Description

It has been reported that patient went under a revision procedure two years and 10 months post-implantation due to implant fracture causing instability.Attempts to obtain additional information have been made; however, no more is available.

Event Description

No additional event information is available at the time of this report.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified that the humeral stem had fractured and humeral bearings are disassembled from the humeral stem.Sem analysis of the humeral stem showed severe post fracture damage to the fracture surface.The humeral stem fracture surface did not reveal any fracture characteristics to identify the mode of fracture, and the crack initiation site on the fracture could not be identified either.The fracture surface showed organic debris, which is likely from post fracture contamination.Eds semi-quantitative elemental analysis of the humeral stem sample showed that it was consistent with ti-6al-4v alloy.It was reviewed from xray that the fractured hardware involving the humeral component of a left total elbow arthroplasty with protrusion of the distal hardware through the bone.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.A summary of the investigation has been sent to the complainant.

• Brand Name: HUMERAL ASSEMBLY
• Type of Device: ELBOW, ARTHROPLASTY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8328825
• MDR Text Key: 135847086
• Report Number: 0001822565-2019-00581
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K001989
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 32810502704
• Device Lot Number: 63019691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 92