MAUDE Adverse Event Report: BIOMET ORTHOPEDICS EXPLOR 12X24 MM IMPLANT HEAD; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Naturally Worn (2988)

Patient Problems Hypersensitivity/Allergic reaction (1907); Irritation (1941)

Event Date 09/12/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent left radial head arthroplasty on (b)(6) 2012.On (b)(6) 2013, the patient underwent debridement and repair due to irritation; (b)(6) 2014 due to radial head loosening, possible metal wear, and possible metal allergies.The head and stem were removed.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: ¿material sensitivity reactions¿ including ¿allergic reaction¿, and ¿loosening or migration of the implants can occur due to loss of fixation¿.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014- 08262 / 08263).

• Brand Name: EXPLOR 12X24 MM IMPLANT HEAD
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4203439
• MDR Text Key: 4983158
• Report Number: 0001825034-2014-08263
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK040611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 11-210042
• Device Lot Number: 720980
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2012
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR