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

Model Number N/A

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 04/01/2016

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.The following could not be completed with the limited information provided.Implant date - (b)(6) 2015.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "fracture of the temporary hemi-hip prosthesis component, made using the stageone select disposable cement spacer molds." this report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2016-01419 / 01420).

Event Description

It was reported a patient underwent a left hip arthroplasty on an unknown date.Subsequently, the patient was revised in (b)(6) 2015 due to unknown reasons.Cement spacer molds were implanted.The patient was further revised on (b)(6) 2016 due to fracture of the cement spacer mold.During the procedure, the distal part of the stem was difficult to remove from the femur and required additional removal of soft tissue.No further information has been provided.

• 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: 5614724
• MDR Text Key: 43877008
• Report Number: 0001825034-2016-01420
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PK080979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2016

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?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 431196
• Device Lot Number: 817130
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2016
• Initial Date FDA Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2015
• 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: 80 YR