MAUDE Adverse Event Report: BIOMET ORTHOPEDICS EXPLOR 8X28MM IMPL STEM W/SCR; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Cyst(s) (1800); Ecchymosis (1818); Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification were not provided in the journal article.The article was written by matthew a.Butler, ginger e.Holt, samuel n.Crosby, and douglas r.Weikert.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 6 states, "nerve injures, including injuries to the ulnar nerve." number 7 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and/or excessive activity." this report is number 3 of 3 mdrs filed for the same patient (reference 1825034-2016-01627 / 01633 / 01636).

Event Description

Information was received based on review of a journal article titled, "late posterior interosseous nerve palsy associated with loosening of radial head implant" which is a case study of one man using an explor (biomet, (b)(4)) press-fit, modular, bond-coated, titanium alloy radial stem.The journal article reports the patient underwent a resection arthroplasty and exploration of the posterior interosseous nerve.The stem and head were removed from the patient.Ecchymosis and an extraosseous hemorrhagic cyst were noted during the procedure.The contents of the cyst included joint fluid, a hemosiderin-laden cyst wall, and hemorrhagic debris.

• Brand Name: EXPLOR 8X28MM IMPL STEM W/SCR
• Type of Device: PROSTHESIS, SHOULDER
• 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: 5664369
• MDR Text Key: 45440203
• Report Number: 0001825034-2016-01636
• 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: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• 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?: Yes
• Date Manufacturer Received: 04/20/2016
• 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): Hospitalization; Required Intervention