MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_ACCOLADE II FEMORAL STEM; UNKNOWN HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 08/05/2014

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding elevated ion levels involving an unknown stem was reported.The event was not confirmed.Method & results: product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.Clinician review: not performed because no medical records or x-rays were made available for evaluation.Product history review: a complaint history review could not be performed as the device was not properly identified.Complaint history review: a complaint history review could not be performed as the device was not properly identified.Conclusions: the event could not be confirmed, nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.Further information such as medical documentation and the return of the devices are needed.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.Product surveillance will continue to monitor for trends.Not available.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2014.It is further alleged that she suffered injuries as a result of the implantation of the device at issue, device recall and excessive levels of cobalt and chromium in her blood.Patient has not yet scheduled a surgery for explantation of the femoral head at issue.

• Brand Name: UNKNOWN_ACCOLADE II FEMORAL STEM
• Type of Device: UNKNOWN HIP 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: evelyn ryan ; raheen business park; limerick NA ; 61498200
• MDR Report Key: 7964694
• MDR Text Key: 123676779
• Report Number: 0002249697-2018-03316
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNWON
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other