MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN HIP; PROSTHESIS, HIP

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913); Naturally Worn (2988)

Patient Problems Discharge (2225); No Code Available (3191)

Event Date 11/14/2007

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Date implanted - (b)(6) 1994; (b)(6) 1995; (b)(6) 1998; (b)(6) 2001.Date explanted - (b)(6) 1995; (b)(6) 1998; (b)(6) 2001.Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure occurred.  should additional information be received regarding the revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, ¿loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity.¿ number 11 states, "wear and/or deformation of articulating surfaces.'.

Event Description

It was reported that clinical patient underwent right total hip arthroplasty on (b)(6) 1994.Subsequently, patient underwent a revision on (b)(6) 1995 due to poly wear.Patient underwent a second revision on (b)(6) 1998 due to acetabular cup migration.Patient underwent a third revision on (b)(6) 2001 due the acetabular cup failing.Patient underwent a fourth revision on (b)(6) 2007 due to wound drainage.During the procedure, irrigation and debridement was performed.No further information has been provided.

• Brand Name: UNKNOWN HIP
• 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: 5398099
• MDR Text Key: 37085754
• Report Number: 0001825034-2016-00287
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• 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: UNKNOWN HIP
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 95