MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RECAP CEMENT FMRL HD RESUR 52M; PROSTHESIS, HIP

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 09/08/2009

Event Type  Injury  

Event Description

It was reported that patient enrolled in a clinical study underwent a right femoral resurfacing procedure on (b)(6) 2007.Subsequently, patient was revised (b)(6) 2009 due to femoral loosening.The femoral head was removed and a stem, modular head and taper adapter were implanted.

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 related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "loosening or migration of implants may occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity.".

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 14 states, ¿intraoperative or postoperative bone fracture of the femoral neck and/or postoperative pain.¿.

Event Description

As part of a retrospective clinical study, a patient was identified who underwent right femoral resurfacing procedure on (b)(6) 2007.Subsequently, the patient experienced a femoral loosening and was revised on (b)(6) 2009.The femoral head was removed and a stem, modular head and taper adapter were implanted.Additional information received revealed the right revision surgery for femoral loosening on (b)(6) 2009 was due to a stress fracture of the femoral neck secondary to avascular necrosis with collapse of the femoral head inside the femoral component of the hip resurfacing.

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

Event description ¿ patient was not enrolled in a clinical study.A retrospective clinical review identified the patient¿s event.

Event Description

As part of a retrospective clinical study, a patient was identified who underwent right femoral resurfacing procedure on (b)(6) 2007.Subsequently, the patient experienced a femoral loosening and was revised on (b)(6) 2009.The femoral head was removed and a stem, modular head and taper adapter were implanted.

• Brand Name: RECAP CEMENT FMRL HD RESUR 52M
• 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: 3924484
• MDR Text Key: 4494812
• Report Number: 0001825034-2014-06017
• 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,Followup
• Report Date: 10/18/2014

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: 03/31/2017
• Device Model Number: N/A
• Device Catalogue Number: US157252
• Device Lot Number: 296880
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2014
• Initial Date FDA Received: 07/09/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/23/2014; 09/29/2014; 11/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2007
• 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: 31 YR
• Patient Weight: 109