MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RECAP PF FMRL HD RESURF 48MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Embolus (1830); Bone Fracture(s) (1870); Toxicity (2333)

Event Type  Injury  

Event Description

It was reported that patient enrolled in a clinical study underwent a right femoral resurfacing procedure on (b)(6) 2011.During post-operative monitoring, elevated metal ion levels, a femoral fracture, pulmonary embolus and unspecified surgical complications were noted.These findings were found due to follow up monitoring, there were no symptoms reported by the patient.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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 9 states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014-06227 / 06228).

Event Description

As part of a retrospective clinical study, a patient was identified who underwent a right femoral resurfacing procedure on (b)(6) 2011.Subsequently, the patient experienced elevated metal ion levels, a femoral fracture and pulmonary embolus.During post-operative monitoring, a trochanteric non-union with broken trochanteric cables, and a trochanteric fracture was noted on (b)(6) 2011.A trochanteric clip was utilized to repair the fracture.

Manufacturer Narrative

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

• Brand Name: RECAP PF FMRL HD RESURF 48MM
• 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: 3938483
• MDR Text Key: 4531569
• Report Number: 0001825034-2014-06227
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK023188
• 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
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: US157148
• Device Lot Number: 653070
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2010
• 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): Required Intervention
• Patient Weight: 52