MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 35MM; SCREW, FIXATION, BONE

Catalog Number 2030-6535-1

Device Problem Failure to Osseointegrate (1863)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

An event regarding loosening involving an other hip screw was reported.The event was confirmed.Method and results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated: "the primary harm involved is aseptic loosening of a tha acetabular implant.No obvious cause for this complication was reported.Further documentation required for completion of this assessment." device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant concluded that the primary harm involved is aseptic loosening of an acetabular implant.As bone screws are intended to provide initial mechanical fixation for a time period of 2 years or less while biological fixation between the acetabular shell and the acetabulum develops, since in the reported event they did not exceeded the time for initial fixation therefore contributed to failure.The exact cause of the event could not be determined because insufficient information was provided.No further investigation for this event is possible at this time.Further information such as return of device, pre and post op xrays from the index surgery and outpatient office/clinic notes are needed to determine the root cause.If devices and/or additional information become available, this investigation will be reopened.Not returned.

Event Description

Patient was revised due to loosening of acetabular component.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 35MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6244214
• MDR Text Key: 64578568
• Report Number: 0002249697-2017-00196
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327037012
• UDI-Public: (01)07613327037012(11)150816(17)200816(10)K88D2M(21)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K894124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2020
• Device Catalogue Number: 2030-6535-1
• Device Lot Number: K88D2M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR