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

Catalog Number	2030-6535-1
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	01/07/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Patient was revised due to loosening of acetabular component.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 35MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6244214
• Report Number: 0002249697-2017-00196
• Device Sequence Number: 10875800
• Product Code: HWC
• UDI-Device Identifier: 07613327037012
• UDI-Public: (01)07613327037012(11)150816(17)200816(10)K88D2M(21)
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2020
• Device Catalogue Number: 2030-6535-1
• Device Lot Number: K88D2M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2016
• Initial Report FDA Received Date: 01/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 61 YR