MAUDE Adverse Event Report: BRAINLAB AG BRAINLAB HIP (VERSION 5.1); STEREOTAXIC INSTRUMENT

Model Number 22000-31C

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 09/08/2014

Event Type  No Answer Provided  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since cup implants were not placed as intended, with the brainlab device involved.A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report to the fda upon completion of investigation.

Event Description

Two hip surgeries have been performed (two patients), whereby the cup implants were placed with the aid of the virtual display of the brainlab navigation.During the procedure the surgeon: positioned the patient in a lateral position.Draped the patient and attached the reference array to the pelvis.Made incision and prepared the pelvis bone.Performed patient registration (acquired anatomical landmarks for the navigation to calculate a virtual display of the patient biomechanics).Reamed the acetabulum with the aid of navigation.Inserted the cup implant with the aid of navigation.Verified the cup position.Ended surgery.The surgeon suspected the cup implant positions to be less than ideal, which proved true since dislocations of the implants occurred post-operatively (1 and 2 months).The surgeon decided to perform revision surgeries for both patients (adding a liner inside the cup for additional stability).According to the hospital, one revision surgery was successful.For the second patient, the revision surgery failed, since the less than ideal cup position could not be addressed sufficiently with the use of the liner.An additional revision surgery is pending.

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since cup implants were not placed as desired, with the brainlab device involved, and revision surgeries were required, although: there is no indication of a systematic error or malfunction of the brainlab device.Corresponding measures are already in place.According to the hospital, the last revision surgeries were successful for both patients and no permanent injuries are present or expected for either patient.Date of events for patient 1: (b)(6) 2014.Date of event for patient 2: (b)(6) 2014.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the cup implants not placed as desired, with the brainlab device involved, lies in the specific surgical technique used in these cases (if/how a potential pelvic tilt is considered for cup implant positioning).There is no indication of any inaccurate or incorrect information virtually displayed by the navigation.Contributing factors for the dislocations are likely related to the specific patients' physiology.There is no indication of a systematic error or malfunction of the brainlab device.Corresponding brainlab measures are already in place.Brainlab intends to: inform this customer about the investigation results re-iterate to this customer the effect of pelvic tilt and how to consider the pelvic tilt in brainlab hip version 6 (which is already installed at this hospital).

Event Description

Two hip surgeries have been performed (two patients), whereby the cup implants were placed with the aid of the virtual display of the brainlab navigation.During the procedure the surgeon: positioned the patient.Draped the patient and attached the reference array to the iliac crest of the pelvis through small stab incisions.Made incision and prepared the pelvis bone.Performed patient registration (acquired anatomical landmarks for the navigation to calculate a virtual display of the patient biomechanics).Reamed the acetabulum with the aid of navigation.Inserted the cup implant with the aid of the navigated cup inserter.Verified the cup position.Continued to femoral preparation, trialing (removing bone and assessing fit with provisional implants) and implantation (non-navigated).Ended surgery.Dislocation of the implants occurred post-operatively (for patient 1, approx.One and sixteen months after the surgery, for patient 2 approx.Five months after the surgery).The surgeon decided to perform revision surgeries for both patients (adding acetabular liners inside the cup for additional stability).For patient 1, two revision surgeries were performed for the left hip (one surgery with aid of navigation, the second surgery without aid of navigation).For patient 2, one revision surgery was performed for the right hip (with aid of navigation).According to the hospital, the last revision surgeries were successful for both patients and no permanent injuries are present or expected for either patient.No further remedial actions (besides the revision surgeries) were reported that would have been necessary.

• Brand Name: BRAINLAB HIP (VERSION 5.1)
• Type of Device: STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer (Section G): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer Contact: andrea miller ; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622 ; 89 9915680
• MDR Report Key: 5623344
• MDR Text Key: 44141970
• Report Number: 8043933-2016-00015
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22000-31C
• Device Catalogue Number: 22000-31C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention