MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6020-0435

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Discomfort (2330); Injury (2348); No Information (3190)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Revision of stem due to head being displaced from trunnion.

Manufacturer Narrative

An event regarding disassociation involving an accolade stem was reported.The event was confirmed.Method and results: device evaluation and results: the device was not returned but images were provided.The stem proximally textured surface demonstrates bony on growth.The stem trunnion shows a deep defect medially approximately two-thirds of the thickness of the neck and a superior trunnion taper to a point with loss of superior lateral trunnion material.Medical records received and evaluation: a review of the provided photographs of explanted components and undated x-rays by a clinical consultant indicated: ¿no clinical or past medical history, no operative reports or examination of the explanted components, and no dated serial x-rays are available for review.Based upon the information available for review, no determination can be made regarding the cause of this clinical situation eight-and-three-quarter years post-implantation of the right total hip arthroplasty.¿ device history review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the exact cause of the reported event could not be confirmed as additional information such as clinical or past medical history; operative reports, dated x-rays and examination of the explanted components are needed to complete the assessment.Review of the medical records indicated ¿¿no determination can be made regarding the cause of this clinical situation eight-and-three-quarter years post-implantation of the right total hip arthroplasty.¿ no further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and /or additional information become available, this investigation will be reopened.

Event Description

Revision of stem due to head being displaced from trunnion.

Event Description

Revision of stem due to head being displaced from trunion.Update 04/30/2018: "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

Additional information provided: a review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.

• Brand Name: ACCOLADE TMZF HIP STEM #4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 5678164
• MDR Text Key: 45861478
• Report Number: 0002249697-2016-01715
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2012
• Device Catalogue Number: 6020-0435
• Device Lot Number: 21792001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/25/2016
• Supplement Dates Manufacturer Received: Not provided; 06/06/2018
• Supplement Dates FDA Received: 09/28/2016; 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 86