MAUDE Adverse Event Report: BIOMET STAGEONE DISPOSABLE CEMENT HIP SPACER FOR TEMPORARY HEMI-SHOULDER PROSTHESIS

Device Problem Off-Label Use (1494)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Neurological Deficit/Dysfunction (1982); Pain (1994); Rash (2033); Toxicity (2333); Reaction (2414); Test Result (2695)

Event Date 02/18/2015

Event Type  Injury  

Event Description

This report involves a biomet hip spacer that was placed inside my left shoulder when the artificial shoulder was removed.On (b)(6) 2013, the orthopedic surgeon ((b)(6)) removed my artificial shoulder again due to infection and placed a biomet shoulder spacer inside my shoulder.I had a lot of pain with that device, and the pain increased over time.I returned to his office multiple times and complained of the increasing pain.I was told "hang in there" and "take pain pills." after the shoulder spacer was inserted, my upper left arm would turn bright, flaming red every 2-3 weeks.I showed it to dr.(b)(6) multiple times and even delivered a letter and photos to his office on (b)(6) 2014.He continued to leave the shoulder spacer in place for a total period of 15 months.He finally removed the shoulder spacer on (b)(6) 2015.I recently learned, while doing my own research, that the fda issued a letter ruling to biomet, the manufacturer, on january 22, 2014, saying the shoulder spacer was supposed to be removed within 180 days (6 months).They violated that ruling and left the hip spacer in my shoulder for 15 months.Here's the direct quote from the fda letter: "the hemi-shoulder prosthesis made from the stageone disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.G.Resection arthroplasty, fusion, etc.)."the manufacturer and surgeons should not be allowed to use the hip spacer inside the shoulder.The hip spacer was not designed for shoulders.My injuries: constant pain throughout the 15 months, increasing pain over that time period that eventually lead to sharp pain that felt like something was cutting me inside my shoulder, ongoing bright red inflammation every 2-3 weeks, multiple red sores on my arms and hands which are now known to be metal poisoning, metal poisoning which is unresolved, extensive neurological damage likely caused by the metal poisoning, increased likelihood of serious health damage and/or death.Please investigate and issue an order putting a stop to this damaging and inhumane practice.

• Brand Name: STAGEONE DISPOSABLE CEMENT HIP SPACER FOR TEMPORARY HEMI-SHOULDER PROSTHESIS
• Type of Device: HIP SPACER
• Manufacturer (Section D): BIOMET
• MDR Report Key: 5113757
• MDR Text Key: 27203873
• Report Number: MW5056613
• Device Sequence Number: 1
• Product Code: KWY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 09/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 98