MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5; IMPLANT

Catalog Number 6021-3535

Device Problems Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Neck Pain (2433); Test Result (2695)

Event Date 12/10/2014

Event Type  Injury  

Event Description

It was reported that surgeon suspected possible trunnionosis.Elevated cobalt chrome levels, soft tissue damage.Hip pain.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available, the evaluation summary will be submitted in a supplemental report.Not returned to manufacturer.

Manufacturer Narrative

An event reporting trunnionosis and elevated cobalt chrome levels (altr) involving an accolade stem was reported.The event was not confirmed based on the medical review.The medical review indicated that "joint fluid levels of cobalt and chromium are not diagnostic and baseline levels in total hip arthroplasty fluid are not determined.One mildly elevated cobalt level in a patient with three metallic arthroplasties is not diagnostic of altr" method & results:-device evaluation and results: not performed as the reported device was not returned for evaluation.The device remains implanted.-medical records received and evaluation: a review of the provided medical records by a clinical consultant concluded: "there is no evidence this patient¿s clinical problems in her left total hip arthroplasty are not entirely due to trochanteric bursitis, which apparently persists after her total hip bearing exchange." -device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including surgical hispathology reports and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

It was reported that surgeon suspected possible trunnionosis.Elevated cobalt chrome levels, soft tissue damage.Hip pain.

Manufacturer Narrative

The patient is (b)(6) in height.An event reporting trunnionosis and elevated cobalt chrome levels (altr) involving an accolade stem was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as the reported device was not returned for evaluation.The device remains implanted.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: "cannot confirm event description, no evidence of altr, need pathology report and readable x-rays" device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including pathology reports, readable x-rays and return of the device are needed to fully investigate the event.

Event Description

It was reported that surgeon suspected possible trunnionosis.Elevated cobalt chrome levels, soft tissue damage.Hip pain.

• Brand Name: ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5
• Type of Device: IMPLANT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4369146
• MDR Text Key: 5285682
• Report Number: 0002249697-2014-05005
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 6021-3535
• Device Lot Number: 35387706
• Other Device ID Number: STERILE LOT 1012RCM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2010
• 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): Required Intervention
• Patient Weight: 78