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

Catalog Number 6021-0435

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Reaction (2414)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

It was reported by the patient's attorney as a result of a legal claim that allegedly the patient had a left total hip arthroplasty on (b)(6) 2008.It is further alleged that the patient had a persistent pain, and elevated cobalt.

Manufacturer Narrative

Reported event: an event regarding alleged ¿corrosion, pain and elevated ion levels¿ involving an accolade stem was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection was not performed as the device was not returned.-medical records received and evaluation: a review of the provided primary and revision operative reports, office notes and x-rays by a clinical consultant indicated: ¿there is no examination of the explanted head and liner, no ct or mri images available for review, and no histopathology diagnostic of altr or pseudotumor.The trunnion, which was cleaned of ¿corrosion¿ was apparently not deformed or degraded and was used to seat a new ceramic head.The stem and acetabular shell were noted to be well-fixed and were retained.There is no evidence that the ¿corrosion¿ noted in the head/trunnion junction after seven years in situ was unexpected.If additional information becomes available this report will be updated.¿ -device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: the reported event was not confirmed nor the exact cause of the event could not be determined because insufficient information was received.Review of the medical records and x-ray by the consulting clinician indicated ¿there is no examination of the explanted head and liner, no ct or mri images available for review, and no histopathology diagnostic of altr or pseudotumor.The trunnion, which was cleaned of ¿corrosion¿ was apparently not deformed or degraded and was used to seat a new ceramic head.The stem and acetabular shell were noted to be well-fixed and were retained.There is no evidence that the ¿corrosion¿ noted in the head/trunnion junction after seven years in situ was unexpected.If additional information becomes available this report will be updated.¿ if additional information and/or device become available, this investigation will be reopened.

Event Description

It was reported by the patient's attorney as a result of a legal claim that allegedly the patient had a left total hip arthroplasty on (b)(6) 2008.It is further alleged that the patient had a persistent pain, and elevated cobalt.Event update as per review of medical records by the consulting clinician dated (b)(6) 2017: "there is no evidence that the ¿corrosion¿ noted in the head/trunnion junction after seven years in situ was unexpected.".

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #4
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6144768
• MDR Text Key: 61433103
• Report Number: 0002249697-2016-03815
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Catalogue Number: 6021-0435
• Device Lot Number: 24820004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2007
• 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: 72 YR
• Patient Weight: 97