MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT

Catalog Number UNK_REC

Device Problems Loose or Intermittent Connection (1371); Metal Shedding Debris (1804)

Patient Problems Unspecified Infection (1930); Discomfort (2330); Complaint, Ill-Defined (2331); Toxicity (2333)

Event Date 11/12/2009

Event Type  Injury  

Event Description

It was reported through the filing of a lawsuit that allegedly the plaintiff was implanted with an accolade tmzf stem on or about (b)(6) 2009 which failed, causing loosening, infection and concentrations of cobalt ions in excess.It is further alleged that the plaintiff was forced to have the device removed.Additional information as per legal: it was reported by the attorney for the patient as a result of a lawsuit that allegedly the patient underwent hip surgery using accolade tmzf hip components on (b)(6) 2009.It is alleged that "after the implantation of the device the patient began experiencing discomfort in the area of his device." it is further alleged that "initial diagnostic workup revealed the absence of device loosening, infection, malposition symptoms.As symptoms persisted, additional diagnostic workup revealed the presence of markedly increased levels of metal ions in the patients' blood and/or urine." on (b)(6) 2013 "metal ion testing revealed concentrations of cobalt ions in excess of 500 mcg/l and patient will be forced to have her device explanted.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported as an lfit anatomic v40 femoral head.The information in this report was provided by stryker.No additional information is available at this time due to ongoing litigation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3995191
• MDR Text Key: 18288745
• Report Number: 0002249697-2014-03072
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2014
• 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): Hospitalization; Required Intervention