MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RECAP PF HA FMRL HEAD RESUR 52MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Embolus (1830)

Event Type  Injury  

Event Description

It was reported that patient enrolled in a clinical study underwent a right femoral resurfacing procedure on (b)(6) 2010.During post-operative monitoring, embolic stroke, retinal embolism and visual field defect was noted on (b)(6) 2010.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.An invoice history could not be located to confirm the surgery date.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Date of event - unknown.Brand name - unknown.Product identification and expiration date - unknown.Date explanted - unknown.510k number - unknown.Manufacture date ¿ unknown.

Manufacturer Narrative

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

Manufacturer Narrative

The follow-up report is being filed to relay corrected and additional information that was unknown at the time of the initial medwatch.Correction: the device product code has been corrected in this report.

Manufacturer Narrative

Corrected data: 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) 2010.Subsequently, the patient experienced embolic stroke, retinal embolism, and a visual field defect; noted on (b)(6) 2010.There has been no reported revision procedure.

Manufacturer Narrative

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

• Brand Name: RECAP PF HA FMRL HEAD RESUR 52MM
• 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: 3941208
• MDR Text Key: 18574427
• Report Number: 0001825034-2014-06234
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK071053
• 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,Followup
• Report Date: 10/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: US157352
• Device Lot Number: 566140
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2009
• 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: 76