MAUDE Adverse Event Report: BIOMET ORTHOPEDICS REGENEREX/RINGLOC+ MULTI HOLE CUP 56MM SZ 24; PROSTHESIS, HIP

Model Number N/A

Device Problems Contamination (1120); Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Toxicity (2333); Ambulation Difficulties (2544)

Event Date 11/01/2011

Event Type  Injury  

Event Description

Legal counsel for patient reports that patient underwent total left total hip arthroplasty on (b)(6) 2010 and that a subsequent revision procedure occurred on (b)(6) 2011, due to patient allegations of elevated metal ion levels, pain, inflammation, difficulty walking, sitting, and standing.A review of invoice history confirmed the acetabular cup, modular head and taper adapter were removed and replaced.Additional information in revision operative notes for the revision procedure that took place on (b)(6) 2011, confirms dislocation and loosening of the acetabular component.Patient medical records further indicate a subsequent revision procedure occurred on (b)(6) 2011, to remove and replace all components with cement spacer molds due to infection.This report is based on patient allegations and the allegations are currently unknown and 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.Review of sterilization certification confirms device was sterilized in accordance with (b)(4).There are warnings in the package insert that state that this type of event can occur: possible adverse effects, number 2 states: ¿early or late postoperative infection and allergic reaction¿.This report is for a 2nd revision and is 3 of 5 mdrs filed for the same event (reference 1825034-2013-06207, 1825034-2014-00288 / 00291.First revision reported on mdrs 1825034-2013-04233 / 04235.

• Brand Name: REGENEREX/RINGLOC+ MULTI HOLE CUP 56MM SZ 24
• Type of Device: PROSTHESIS, HIP
• 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: 3567437
• MDR Text Key: 16450913
• Report Number: 0001825034-2014-00289
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: PT-106056
• Device Lot Number: 476410
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2013
• Initial Date FDA Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2010
• 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
• Patient Age: 65 YR