MAUDE Adverse Event Report: BIOMET ORTHOPEDICS REINFORCED HIP MOLD STEM 9X200MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Bent (1059); Break (1069); Fracture (1260)

Patient Problems Unspecified Infection (1930); No Information (3190)

Event Date 11/12/2015

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.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 prosthesis component, made using the stageone disposable cement spacer molds.".

Event Description

It was reported a patient underwent an initial left hip arthroplasty in (b)(6) 2013.Subsequently, the patient was revised on (b)(6) 2015 due to infection.Cement spacer stem and head were implanted.It was reported one week after surgery, the cement spacer stem had bent and subsequently fractured in (b)(6) 2015.The patient was revised on (b)(6) 2015 due to the fractured cement spacer stem.A girdlestone procedure was performed and a new cement spacers were implanted.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information and additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported a patient underwent an initial left hip arthroplasty on (b)(6) 2014 with competitor product.Subsequently, patient underwent a revision procedure on (b)(6) 2014 due to periprosthetic fracture.Patient was revised on (b)(6) 2015 due to recurrent infection.Cement spacer stem and head were implanted.It was reported one week after surgery, the cement spacer stem had bent and subsequently fractured in (b)(6) 2015.The patient was revised on (b)(6) 2015 due to the fractured cement spacer stem.A girdlestone procedure was performed and a new cement spacers were implanted.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.During the evaluation, the cement spacer showed evidence of fracture and collapsed air bubbles.Root cause of the event was most likely attributed to patient being load bearing after spacer placement; however, a conclusive root cause could not be determined.There are warnings in the package insert that state that this type of event can occur: under warnings, number 1 states, "imperfections can significantly decrease the strength of the temporary hemi-hip prosthesis.Do not implant temporary hemi-hip prosthesis with voids, air pockets, or cracks in the cement." number 4 states, "the patient is to be warned that there is a risk of temporary hemi-hip prosthesis fracture upon full weight bearing or high activity.".

• Brand Name: REINFORCED HIP MOLD STEM 9X200MM
• 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: 5353618
• MDR Text Key: 35357441
• Report Number: 0001825034-2016-00097
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup,Followup
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 431195
• Device Lot Number: 061840
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2015
• 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 Weight: 80