MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TITANIUM SCREW LOW PROFILE 5X40MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/03/2015

Event Type  Injury  

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 or deviation.Possible lot number: 586970.Concomitant medical product - biomet m2a cup catalog#: 15-105058 lot#: 533170; biomet femoral stem catalog#: 11-103207 lot#: 900190.This report is number 2 of 3 mdr's filed for the same patient (reference 1825034-2016-02878, 04756 and 04767).

Event Description

It was reported that during a left hip revision procedure, an acetabular screw fractured upon removal from the cup.A fragment of the proximal portion of the screw was retained by the patient.

Manufacturer Narrative

The 510(k) number updated to k991807.

• Brand Name: TITANIUM SCREW LOW PROFILE 5X40MM
• Type of Device: PROSTHESIS, SHOULDER
• 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: 6115370
• MDR Text Key: 60411987
• Report Number: 0001825034-2016-04756
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK991807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 113848
• Device Lot Number: 581380
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Disability
• Patient Age: 63 YR