MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE TMZF HIP STEM; HIP IMPLANT

Catalog Number UNK_SHC

Device Problems Corroded (1131); Fracture (1260); Material Separation (1562); Device Operates Differently Than Expected (2913); Material Deformation (2976); No Apparent Adverse Event (3189)

Patient Problems Tissue Damage (2104); Discomfort (2330); Injury (2348); Not Applicable (3189)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported through the filing of a lawsuit that allegedly after implantation of the device the patient began experiencing discomfort in the area of his device and later catastrophic total hip replacement failure with trunnionosis and a femoral neck fracture with dissociation of the femoral head.It is further alleged that as a result the patient was forced to have the devices surgically removed and during removal, it was apparent the device had failed causing gross deformation of the accolade tmzf stem together with severe and permanent tissue and muscle damage.

Manufacturer Narrative

An event regarding disassociation and tissue damage involving an unknown accolade stem was reported.The event was not confirmed.Method and results: -device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.-medical records received and evaluation: no information was received for review with the clinical consultant.-device history review could not be performed as the device lot is unknown.-complaint history review could not be performed as the device lot is unknown.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

It was reported through the filing of a lawsuit that allegedly after implantation of the device the patient began experiencing discomfort in the area of his device and later catastrophic total hip replacement failure with trunnionosis and a femoral neck fracture with dissociation of the femoral head.It is further alleged that as a result the patient was forced to have the devices surgically removed and during removal, it was apparent the device had failed causing gross deformation of the accolade tmzf stem together with severe and permanent tissue and muscle damage.

Manufacturer Narrative

Event - it was determined that this event is a duplicate of mfr.Report # 0002249697-2016-01715.Investigations and conclusions were documented under this manufacturer report number.

Event Description

Event - it was determined that this event is a duplicate of mfr.Report # 0002249697-2016-01715.Investigations and conclusions were documented under this manufacturer report number.It was reported through the filing of a lawsuit that allegedly after implantation of the device the patient began experiencing discomfort in the area of his device and later catastrophic total hip replacement failure with trunnionosis and a femoral neck fracture with dissociation of the femoral head.It is further alleged that as a result the patient was forced to have the devices surgically removed and during removal, it was apparent the device had failed causing gross deformation of the accolade tmzf stem together with severe and permanent tissue and muscle damage.

• Brand Name: UNKNOWN ACCOLADE TMZF HIP STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6373290
• MDR Text Key: 68846472
• Report Number: 0002249697-2017-00777
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention