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

Model Number N/A

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Device Slipped (1584)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Toxicity (2333); Limited Mobility Of The Implanted Joint (2671)

Event Date 06/06/2012

Event Type  Injury  

Event Description

Patient's legal counsel reports patient underwent a left total elbow arthroplasty on (b)(6) 2009.Subsequently, patient underwent a heterotopic ossification removal and contracture release procedure on (b)(6) 2009.It was further reported patient underwent a revision procedure on (b)(6) 2010, due to patient allegations of pain, swelling, and limited range of motion.Subsequently, patient underwent a revision procedure on (b)(6) 2012, due to pain, swelling, limited range of motion, loosening and metallosis.Review of operative notes indicate an incision and drainage with debridement and synovectomy procedure was performed.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

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: under possible adverse effects, number 1 states, ¿material sensitivity reactions.¿ number 6 states, ¿inadequate range of motion due to improper selection or positioning of components.¿ number 14 states, ¿intraoperative or postoperative bone fracture and/or postoperative pain.¿ number 15 states, ¿elevated metal ion levels have been reported with metal-on-metal articulating surfaces.¿ the following sections could not be completed with the limited information provided.Explant date - it is unclear if product was removed during the (b)(6) 2010 procedure or (b)(6) 2012 procedure.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014-01625 / 01626).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Examination of returned device found no evidence of product non-conformance.Review of the device confirmed the reported condition as the radial head was found loose on the stem.The thread form on the stem was inspected and found to be conforming; therefore, a conclusive root cause of the event could not be determined.Correction: there are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, ¿material sensitivity reactions.¿ number 6 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption and/or excessive activity." number 8 states, "inadequate range of motion due to improper selection or positioning of components.¿ number 14 states, ¿intraoperative or postoperative bone fracture and/or postoperative pain.¿.

• Brand Name: EXPLOR 8X28MM 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3679836
• MDR Text Key: 20271419
• Report Number: 0001825034-2014-01626
• 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: Other,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• 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: 11-210063
• Device Lot Number: 663540
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2008
• 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