MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH FEM STEM-HI OFFSET NK-SIZE 1 IMPLANT; HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

Catalog Number 186004-01

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 02/10/2015

Event Type  Injury  

Event Description

The surgeon performed a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).During the case, the surgeon fractured the patient's femur while inserting the stem.The patient's femur was cabled and the outcome of the case was successful.

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event is being completed at mako surgical.A supplemental report will be filed when additional information is obtained.

Manufacturer Narrative

Clinician review: a review of the provided medical records and x-rays by a clinical consultant concluded: "no patient demographics, no clinical or past medical history, and no operative report are available for review.There is no indication that factors of faulty component design, manufacturing, or materials were responsible for this clinical situation." device history review of the device based on the reported lot, it was manufactured around 30-nov-2014.Complaint history review there have been no other events for the reported lot.The event was confirmed by the medical records submitted.However, the root cause of the reported event could not be determined due to the minimal information received.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

The surgeon performed a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio).During the case, the surgeon fractured the patient's femur while inserting the stem.The patient's femur was cabled and the outcome of the case was successful.

• Brand Name: FEM STEM-HI OFFSET NK-SIZE 1 IMPLANT
• Type of Device: HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4600139
• MDR Text Key: 20152322
• Report Number: 3005985723-2015-00032
• Device Sequence Number: 1
• Product Code: OQI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 186004-01
• Device Lot Number: 100141-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2014
• 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): Disability
• Patient Age: 77 YR