MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ACT ARTIC E1 HIP BRG 28X48MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Difficult to Remove (1528); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Seroma (2069); Toxicity (2333)

Event Date 01/28/2014

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent right total hip arthroplasty on (b)(6) 2011.Patient's legal counsel further reported that a revision procedure was performed on (b)(6) 2013 due to patient allegations of pain.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received in operative (op) notes dated (b)(6) 2013 reports patient was revised due to pain, elevated cobalt and chromium ion levels, and questionable stability.Revision op report notes after the head was removed, approximately an hour and a half was taken in an unsuccessful attempt to remove the taper.The taper could not be removed and had to be cut off, which took an additional hour.In addition, op notes report there was corrosion around the femoral neck.The cup, modular head, and taper were removed and replaced.Additional information received in op notes reports patient underwent a second revision procedure on (b)(6) 2014 due to dislocation and disassociation of the tripolar component.Revision op report notes the presence of a seroma.The liner, head, and taper sleeve were removed and replaced.

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.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 6 of 6 mdrs filed for the same event (reference 1825034-2014-03095 and -07190 / -07194).

Manufacturer Narrative

This follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.This report is number 6 of 8 mdr's filed for the same patient (reference 1825034-2014-03095, -07190 / -07194, and -09286 & -09288).

Event Description

Legal counsel for patient reported that patient underwent right total hip arthroplasty on (b)(6) 2011.Patient's legal counsel further reported that a revision procedure was performed on (b)(6) 2013 due to patient allegations of pain.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information received in operative (op) notes dated (b)(6) 2013 reports patient was revised due to pain, elevated cobalt and chromium ion levels, and questionable stability.Revision op report notes after the head was removed, approximately an hour and a half was taken in an unsuccessful attempt to remove the taper.The taper could not be removed and had to be cut off, which took an additional hour.In addition, op notes report there was corrosion around the femoral neck.The cup, modular head, and taper were removed and replaced.Additional information received in op notes reports patient underwent a second revision procedure on (b)(6) 2014 due to dislocation and disassociation of the tripolar component.Revision op report notes the presence of a seroma.The liner, head, and taper sleeve were removed and replaced.Review of invoice records reveals patient underwent an additional revision procedure on (b)(6) 2014 due to dislocation.The freedom constrained head and liner were removed and replaced.

• Brand Name: ACT ARTIC E1 HIP BRG 28X48MM
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4024632
• MDR Text Key: 4725748
• Report Number: 0001825034-2014-07194
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: EP-200154
• Device Lot Number: 281310
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2013
• 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: 57 YR