MAUDE Adverse Event Report: BIOMET ORTHOPEDICS EXPLOR 8X28MM IMPLANTABLE STEM WITH SCREW; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Halverson et al."clinical outcomes of biomet explor modular radial head arthroplasty system." pg.1-33.Reference journal article attached.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A review of the complaint history determined that no further action is required.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Concomitant medical devices - explor 10x20mm implant modular radial head, catalog #: 11-210022, lot #: ni.(b)(6).This report is number 2 of 2 mdrs filed for the same patient (reference 0001825034-2017-02232).

Event Description

It is reported in a journal article that one patient experienced moderate elbow pain fifty-three months following right radial head arthroplasty.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: EXPLOR 8X28MM IMPLANTABLE STEM WITH SCREW
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6498485
• MDR Text Key: 72963542
• Report Number: 0001825034-2017-02621
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 11-210063
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 27 YR