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

Model Number N/A

Device Problem Entrapment of Device (1212)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet unknown head catalog#: unknown, lot#: unknown; biomet unknown stem, catalog#: unknown, lot#: unknown.Current information is insufficient to permit a conclusion as to the cause of the event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported in a journal article titled, "reduction in early dislocation rate with large-diameter femoral heads in primary total hip arthroplasty" that one acetabular component as revised due to impingement.The journal article further reported that the patient's hip had compromised bone stock or unusual anatomy.Attempts to obtain additional information have been made; however, no more is available at this time.Patient outcome is unknown.

• Brand Name: UNKNOWN SHELL
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6433106
• MDR Text Key: 70858424
• Report Number: 0001825034-2017-01863
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2017

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/24/2017
• 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