MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RECAP CEMENTED FEMORAL HEAD RESURFACING 46M; PROSTHESIS, HIP

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Date 03/05/2012

Event Type  Injury  

Event Description

It was reported that patient enrolled in a clinical study underwent a right femoral resurfacing procedure on (b)(6) 2006.Subsequently, patient experienced pain and femoral loosening.There has been no reported revision procedure to date; however, a revision procedure has been recommended.

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 possible adverse effects: loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.Intraoperative or postoperative bone fracture of the femoral neck and/or postoperative pain.

Manufacturer Narrative

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

Event Description

It was reported that a patient enrolled in a clinical study underwent a right femoral resurfacing procedure on (b)(6) 2006.Subsequently, patient was revised on (b)(6) 2012 due to pain and femoral loosening.The femoral stem was removed and replaced.

Manufacturer Narrative

This medwatch 0001825034-2014-05935 is a duplicate of medwatch 0001825034-2014-04116.This medwatch 0001825034-2014-05935 is considered closed at this time.

• Brand Name: RECAP CEMENTED FEMORAL HEAD RESURFACING 46M
• 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: 3915334
• MDR Text Key: 4514522
• Report Number: 0001825034-2014-05935
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK021799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2016
• Device Model Number: N/A
• Device Catalogue Number: US157246
• Device Lot Number: 398540
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2006
• 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