MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-0637

Device Problems Corroded (1131); Device Slipped (1584); Metal Shedding Debris (1804); Loss of Osseointegration (2408); Material Deformation (2976)

Patient Problems Necrosis (1971); Injury (2348); Inadequate Osseointegration (2646)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The distributor reported revision surgery undertaken for loose stem.Primary surgery was undertaken in 2009.Revision undertaken on (b)(6) 2017 during surgery a large greater trochanteric bursa and grey green necrotic material were noticed.The stem was loose with black discoloration at head and neck junction.

Manufacturer Narrative

An event regarding alleged loosening and corrosion involving an accolade stem was reported.The event was confirmed.Device evaluation and results: a material analysis has been performed.The report concluded: "damage was observed on the accolade trunnion and v40 head taper.This damage was consistent with cyclic movement between the trunnion and the female taper, a result likely due to a loss of taper lock between the two components.Eds analysis performed on the debris from the stem neck/trunnion junction indicated the presence of corrosion products.No materials or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: a review of the provided office notes, primary and revision operative reports and x-rays by a clinical consultant indicated: "no clinical or past medical history, no serial x-rays, no histopathology are available regarding this case.A material analysis report dated march 16, 2017 of a #6 accolade plus tmzf stem, a 3/plus-5 v-40 lfit head.Includes ten photographs of the cleaned, explanted components including close-ups of the trunnion head, one eds graph of the base material of the stem, and one eds graph of the debris material from the stem.The conclusions of this report are: (1) damage was observed on the accolade trunnion and v-40 head taper consistent with cyclic movement at the junction likely due to a loss of taper lock; (2) eds analysis of the debris from the neck/trunnion junction indicated presence of corrosion products; and (3) no material or manufacturing defects were observed.Based upon the information available for review, no determination can be made regarding the apparent loss of the head/trunnion taper lock resulting in the revision surgery eight years post-implantation.Additional x-rays were reviewed and the clinician noted: "review of this additional documentation does not alter the conclusions of my earlier report." 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 material analysis confirms the corrosion and noted the damage/corrosion between the trunnion and female taper is likely due to a loss of taper lock between the two components.Medical records confirm loosening however the root cause for loosening cannot be determined based off of the information provided.If additional information and/or device become available, this investigation will be reopened.

Event Description

The distributor reported revision surgery undertaken for loose stem.Primary surgery was undertaken in 2009.Revision undertaken on (b)(6) 2017.During surgery a large greater trochanteric bursa and grey green necrotic material were noticed.The stem was loose with black discoloration at head and neck junction.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #6
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6356648
• MDR Text Key: 68269744
• Report Number: 0002249697-2017-00650
• 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: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/26/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2012
• Device Catalogue Number: 6021-0637
• Device Lot Number: 21927701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: 11/28/2017
• Supplement Dates FDA Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2007
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 93