MAUDE Adverse Event Report: BIOMET ORTHOPEDICS HIP MOLD STEM W/REINF 11X200; PROSTHESIS, HIP

Model Number N/A

Device Problems Bent (1059); Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that patient underwent a bilateral hip arthroplasty on an unknown date.Subsequently, patient underwent a revision procedure on (b)(6), 2014 where spacer molds were implanted due to infection.It was further reported that the femoral stem bent resulting in a fractured femur.Subsequently, patient underwent a revision procedure on an unknown date where the spacer molds were removed.A review of the invoice history confirmed the (b)(6), 2014 surgery date.

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.There are warnings in the package insert that state that these types of events can occur: under contraindications, number 4 states, "poor bone quality (as in osteoporosis) could cause the hemi-hip prosthesis to migrate or to fracture host bone.".

• Brand Name: HIP MOLD STEM W/REINF 11X200
• 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: 3947862
• MDR Text Key: 4641808
• Report Number: 0001825034-2014-06334
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 431196
• Device Lot Number: 891820
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2012
• 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