MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TI LOW PROFILE SCREW 6.5X25MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Swelling (2091); Tissue Damage (2104); Toxicity (2333); No Information (3190)

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.The following section could not be completed with the limited information provided.Date explanted: remains implanted.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 3 states, ¿loosening or migration of the implant.¿ this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 3 of 5 mdr's filed for the same event (reference 1825034-2014-00893-4 / 2014-04387-3 / 2015-04929 / 2015-04930 and 2015-04931).

Event Description

Legal counsel for patient reported that patient underwent an initial right hip arthroplasty on (b)(6) 2005.Patient's legal counsel further reported that a revision procedure was performed on (b)(6) 2012 due to patient allegations of pain, elevated metal ion levels, and tissue and bone destruction.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.Additional information received from patient's operative (op) report notes patient was revised (b)(6) 2012 due to metallosis and pseudotumor.Revision op notes report the presence of periprosthetic pseudotumor, a greater trochanteric fracture, and joint fluid.In addition, the cup was observed to be anteverted and vertical.The cup and head were removed and replaced.Additional information received note a custom triflange cup was created for the right hip revision on (b)(6) 2015 due to a loose acetabular cup.Additional information received reported patient dislocated right hip on (b)(6) 2015 and underwent a closed reduction.Additionally, patient underwent an initial left hip arthroplasty on (b)(6) 2009.Subsequently, the patient is scheduled for a future revision on the left side due to loose screws.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Quantity: 3.This is 1 of 13 devices that may have been involved in the event, as it is unknown which device malfunctioned.This report is number 3 of 20 mdrs filed for the same event (reference 1825034-2014-00893, 2014-04387, 2015-04929/31, 2016-02826/37, and 2016-02823/25).Product location unknown.

Event Description

It was reported that patient underwent a left hip revision procedure due to loosening of screws.During the procedure, the triflange was removed and replaced.

• Brand Name: TI LOW PROFILE SCREW 6.5X25MM
• 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: 5276629
• MDR Text Key: 32986115
• Report Number: 0001825034-2015-04929
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 103532
• Device Lot Number: 529760
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2009
• 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