MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ULNAR STEM; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Unspecified Infection (1930); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: unknown, unknown srs humeral stem, unknown.Customer has been indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 09767.

Event Description

It was reported that a patient underwent an elbow procedure on an unknown date.Subsequently, the patient is being considered for a revision on an unknown day due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.

Event Description

It was reported that a patient underwent an elbow procedure.Subsequently, the patient fell and experienced a distal radius fracture and was casted.The patient had a wound on the elbow that became infected.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined that this device did not cause or contribute to the event and should not have been reported.The initial report should be voided as it was submitted in error.

• Brand Name: UNKNOWN ULNAR STEM
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6996089
• MDR Text Key: 90875727
• Report Number: 0001825034-2017-09768
• Device Sequence Number: 1
• Product Code: KXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 47