MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LEGEND. V40(TM) FEMORAL STEM; HIP IMPLANT

Catalog Number 4401-0-401

Device Problems Break (1069); Fracture (1260)

Patient Problem Injury (2348)

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

Hospital representative reported the following event : "spontaneous rupture (without any notion of trauma) of a ceramic total hip replacement feed.".

Manufacturer Narrative

An event regarding crack/fracture involving a femoral stem was reported.Based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event.The event description details spontaneous rupture of a ceramic component.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Hospital representative reported the following event : "spontaneous rupture (without any notion of trauma) of a ceramic total hip replacement feed.".

• Brand Name: LEGEND. V40(TM) FEMORAL STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8203962
• MDR Text Key: 131647166
• Report Number: 0002249697-2018-04162
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4401-0-401
• Device Lot Number: GX297569
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 92