MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VHS LAG SCR 12.7X95 W/COMP SCREW; APPLIANCE, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 04/07/2015

Event Type  Injury  

Event Description

Legal counsel for patient reported that the patient underwent a total hip arthroplasty on (b)(6) 2009.Subsequently, legal counsel reported a revision procedure has been indicated due to an unknown reason; however, no revision has been reported to date.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

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: brand name, product / lot code / expiration date, pma/510(k) number, manufacture date.Event is being reported to fda on one medwatch as the limited information available indicates that a revision has occurred.Should additional information be received, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

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

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

Event Description

Legal counsel for patient reported that the patient underwent a total hip arthroplasty on (b)(6) 2009.Subsequently, legal counsel reported a revision procedure has been indicated due to an unknown reason; however, no revision has been reported to date.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information received in operative report noted patient underwent a left open reduction and internal fixation procedure on (b)(6) 2009.Subsequently, patient underwent a revision procedure on (b)(6) 2015 due to pain.Operative report further noted all components were removed during the revision procedure.

• Brand Name: VHS LAG SCR 12.7X95 W/COMP SCREW
• Type of Device: APPLIANCE, FIXATION
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 399 jefferson road; parsippany NJ 07054 0346
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 399 jefferson road; parsippany NJ 07054 0346
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4565386
• MDR Text Key: 5556364
• Report Number: 0001825034-2015-00773
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK964880
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 200195
• Device Lot Number: 804560
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2009
• 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): Required Intervention
• Patient Age: 79 YR