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

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Device Slipped (1584); Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 04/08/2013

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, initial revision - (b)(6) 1994.Date implanted, (b)(6) 2013 revision - unknown.Date explanted, initial revision - unknown.Date explanted, (b)(6) 2013 revision - (b)(6) 2013.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.

Event Description

It was reported patient underwent a right total hip arthroplasty on (b)(6) 1994.Subsequently, patient was on and unknown date due to unknown reasons.Further, patient was revised on (b)(6) 2013 due to aseptic loosening of the acetabular component with migration, osteolysis, and polyethylene wear.Operative notes indicate fractured screws with the acetabular component and severe osteolysis.

Event Description

It was reported patient underwent a right total hip arthroplasty on (b)(6) 1994.Subsequently, patient was revised on an unknown date due to unknown reasons.Further, patient was revised on (b)(6) 2013 due to aseptic loosening of the acetabular component with migration, osteolysis, and polyethylene wear.Operative notes indicate fractured screws within the acetabular component and severe osteolysis.

• 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: 5138133
• MDR Text Key: 27910967
• Report Number: 0001825034-2015-04220
• Device Sequence Number: 1
• Product Code: KWA
• 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: Followup
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• 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: 10/16/2015
• 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 Age: 65 YR
• Patient Weight: 98