MAUDE Adverse Event Report: BIOMET ORTHOPEDICS E-POLY 40MM +3 HIWALL LNR SZ24; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Device Slipped (1584); Unstable (1667); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 12/03/2015

Event Type  Injury  

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.Date of event - procedure has not yet occurred.Date explanted - device still implanted.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 8 states, "dislocation and subluxation due to inadequate fixation, malalignment, malposition, excessive, unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity.Muscle and fibrous tissue laxity can also contribute to these conditions.¿ this report is number 3 of 5 mdr's filed for the same event (reference 1825034-2015-04099 / 04262 / 04263 / 04264 / 04265).

Event Description

It was reported a bilateral patient underwent a left total hip arthroplasty on (b)(6) 1995 and a right total hip arthroplasty on (b)(6) 1990.Subsequently, operative notices indicate the patient underwent a right revision procedure on (b)(6) 1999 due to poly wear and dislocations.The acetabular cup was removed and a competitor cup was implanted.The patient was revised on (b)(6) 2000 for unknown reasons on an unknown side.The modular head was removed and replaced.On (b)(6) 2011 the patient dislocated on the right side and underwent a revision procedure.Operative notes report patient underwent a revision procedure on (b)(6) 2011 due to loosening of the cup, fractured screw, chronic dislocation, osteolysis, impingement, instability and soft tissue deficiencies.Operative report further noted the cup and head were removed and replaced during the revision procedure.A future revision has been indicated due to dislocations and a loose cup with a fractured screw.

Manufacturer Narrative

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

Event Description

It was reported a bilateral patient underwent a left total hip arthroplasty on (b)(6) 1995 and a right total hip arthroplasty on (b)(6) 1990.Subsequently, operative notices indicate the patient underwent a right revision procedure on (b)(6) 1999 due to poly wear and dislocations.The acetabular cup was removed and a competitor cup was implanted.The patient was revised on (b)(6) 2000 for unknown reasons on an unknown side.The modular head was removed and replaced.On (b)(6) 2011 the patient dislocated on the right side and underwent a revision procedure.Operative notes report patient underwent a right revision procedure on (b)(6) 2011 due to loosening of the cup, fractured screw, chronic dislocation, osteolysis, impingement, instability and soft tissue deficiencies.Operative report further noted the cup and head were removed and replaced during the revision procedure.A future revision has been indicated due to dislocations and a loose cup with a fractured screw.Additional information received reported patient was revised on (b)(6) 2015.

• Brand Name: E-POLY 40MM +3 HIWALL LNR SZ24
• 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: 5140727
• MDR Text Key: 27960809
• Report Number: 0001825034-2015-04263
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK090103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/29/2016
• Device Model Number: N/A
• Device Catalogue Number: EP-108524
• Device Lot Number: 878970
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2011
• 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: 79 YR