MAUDE Adverse Event Report: BIOMET ORTHOPEDICS EXPLOR 6X24MM IMPL STEM W/SCR; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

A1- cmp-0279295 e1 - initial reporter - the article was written by schuyler j halverson, mihir j desai and donald h lee.H3 - the complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt ofadditional information.Halverson et al."clinical outcomes of biomet explor modular radial head arthroplasty system" journal title.37:853-858.Pg.1-33.D11 - medical products - explor radial head: catalog #11-210032, lot # ni the reported event was unable to be confirmed as the lot number of device involved in the incident is unknown.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the lot number is unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported in a journal article that the patient experienced moderate wrist pain, severe elbow pain, and lucency approximately 26 months post-implantation of a left radial head arthroplasty.No further information is available.

• Brand Name: EXPLOR 6X24MM IMPL STEM W/SCR
• 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: 6519268
• MDR Text Key: 73615635
• Report Number: 0001825034-2017-02737
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 11-210061
• 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
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Other
• Patient Age: 63 YR