MAUDE Adverse Event Report: BIOMET ORTHOPEDICS SIRIUS HIP STEM 34-B; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/03/2014

Event Type  Injury  

Event Description

It was reported patient underwent a right total hip arthroplasty on (b)(6) 2014.During the procedure, the patient's femur cracked while implanting the cement plug.A cable was utilized to secure the fracture.Subsequently, leg length discrepancy was noted and post operative radiographs and templating suggests the incorrect stem was implanted.The packaging was mislabeled.There has been no reported revision procedure to 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 this type of event can occur: under possible adverse effects, number 14 states, "postoperative bone fracture and pain.".

Manufacturer Narrative

Decision was made to recall based on an investigation which identified that an order was mixed and could result in the incorrect sized femoral stem being implanted into a patient.(b)(4).

Event Description

It was reported patient underwent a right total hip arthroplasty on (b)(6) 2014.During the procedure, the patient's femur cracked while implanting the cement plug.A cable was utilized to secure the fracture.Subsequently, leg length discrepancy was noted and post-operative radiographs suggested the incorrect sized stem was implanted.A revision procedure was performed on (b)(6) 2014 and the stem was replaced with the size that was originally intended.

Manufacturer Narrative

Further investigation into this issue is in process.Upon completion of investigation, a follow up report will be sent to the fda.

Event Description

It was reported patient underwent a right total hip arthroplasty on (b)(6) 2014.During the procedure, the patient's femur cracked while implanting the cement plug.A cable was utilized to secure the fracture.Subsequently, leg length discrepancy was noted and post operative radiographs which suggested the incorrect stem was implanted.Further investigation into the issue revealed that the label on the stem had the incorrect size listed.A revision procedure was performed on (b)(6) 2014 and the stem was replaced with the size that was originally intended.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

• Brand Name: SIRIUS HIP STEM 34-B
• 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: 4120681
• MDR Text Key: 4926423
• Report Number: 0001825034-2014-07881
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK130610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 51-199333
• Device Lot Number: 024320
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1825034-2014-011R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR