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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Type  Injury  

Event Description

It was reported that patient enrolled in a clinical study underwent left femoral resurfacing procedure on (b)(6) 2008.Subsequently, patient experienced a small embolic stroke on an unknown date and was treated with anticoagulants.There has been no reported revision procedure to 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.Product identification/expiration date - unknown.Pma/510(k) number - unknown.Manufacture date ¿ unknown.Event is being reported to fda on one medwatch as the limited information available indicates that a medical complication occurred.Should additional information be received regarding the procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.

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

The follow-up report is being filed to relay corrected information that was unknown at the time of the initial medwatch.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 a left femoral resurfacing procedure on (b)(6) 2008.Subsequently, patient experienced a small embolic stroke on an unknown date and was treated with anticoagulants.There has been no reported revision procedure to date.

• 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: 3921611
• MDR Text Key: 4586736
• Report Number: 0001825034-2014-06037
• 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: 10/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: N/A
• Device Catalogue Number: US157252
• Device Lot Number: 613460
• 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: 05/11/2007
• 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
• Patient Weight: 98