MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TITANIUM SCREW LOW PROF 5X35MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/15/2014

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.Four screws have been reported for this event as it is unknown which of the screws fractured or were loose.Explant date - could be (b)(6) 2016 or may remain implanted.This report is number 10 of 13 mdr's filed for the same patient (reference 1825034-2014-07370, 07371, 07372, 07373, 07375 and 2016-02250, 02251, 02253, 02255, 02256, 02257, 02260, 02261.There are warnings in the package insert that these types of events may occur.Under possible adverse effects, number 10 states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight." product location unknown.

Event Description

Patient's legal counsel reported that patient underwent a right hip revision procedure approximately nine (9) years post-implantation due to allegations of metallosis and elevated metal ion levels.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Operative reports received confirm patient was revised approximately nine (9) years post-implantation due to pain, instability, osteolysis, migration of the acetabular cup and metal debris.During the revision procedure, yellow fluid, loose and vertical cup, two loose screw and two fractured screws were noted.The loose screws were removed and the fractured screws remain in the patient.The modular head and acetabular cup were removed and replaced with a liner.Two acetabular cups were used to complete the procedure, with one placed inside the other for stability.

• Brand Name: TITANIUM SCREW LOW PROF 5X35MM
• 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: 5746334
• MDR Text Key: 48093796
• Report Number: 0001825034-2016-02257
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2013
• Device Model Number: N/A
• Device Catalogue Number: 113847
• Device Lot Number: 241760
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2003
• 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: 60 YR