MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 6021-3535

Device Problems Degraded (1153); Metal Shedding Debris (1804); Material Integrity Problem (2978)

Patient Problems Toxicity (2333); Injury (2348); Reaction (2414)

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

The 36mm + 0 metal v-40 head had shaved off a little part of the trunnion.The patient had high metal levels and had metallosis on the base of the trunnion where it meets the head.The head was removed & metallosis was cleaned up.The trunnion did not have serious damage so we went back with a ceramic 36 + 5 head.

Manufacturer Narrative

An event regarding the "v-40 head had shaved off a little part of the trunnion" (wear) involving an accolade stem was reported.The event was confirmed.Method & results: -device evaluation and results: the device was not returned.Images of the stem implanted were provided.It was noted the trunnion did not have serious damage and remained implanted.-medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: "cobalt and chromium levels were drawn and found to be 7.5 and 1.8 respectively.Because her physicians felt her systemic complaints related to metal toxicity a revision surgery was undertaken.At the time of surgery only in small fluid was encountered.No metallic debris was noted.Some burnishing was noted around the trunion.No gross corrosion or fretting was reported.The primary harm involved is pain.No obvious source for this pain was identified.Suspicions of metal toxicity were not supported her preoperative lab work or her intraoperative findings.No evidence of implant or manufacturing defect was identified." -device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: review of medical records by a consulting clinician confirmed the event as noted: "some burnishing was noted around the trunion.No evidence of implant or manufacturing defect was identified." the photo also confirms wear on the trunnion.If further information and/or the device becomes available this investigation will be reopened.

Event Description

The 36mm + 0 metal v-40 head had shaved off a little part of the trunnion.The patient had high metal levels and had metallosis on the base of the trunnion where it meets the head.The head was removed & metallosis was cleaned up.The trunnion did not have serious damage so we went back with a ceramic 36 + 5 head.

• Brand Name: ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6086612
• MDR Text Key: 59412349
• Report Number: 0002249697-2016-03484
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2012
• Device Catalogue Number: 6021-3535
• Device Lot Number: 24730604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2007
• 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: 81 YR
• Patient Weight: 82