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

Catalog Number UNK_SHC

Device Problem Corroded (1131)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Tissue Damage (2104); Toxicity (2333)

Event Date 04/14/2015

Event Type  Injury  

Event Description

It was reported by the attorney for the patient as a result of a legal claim, that allegedly the patient had a total hip replacement in 2009 where he received an accolade #5 hip stem.It is further alleged that after experiencing pain, swelling, and inflammation around the implant site, the patient saw several doctors and it was determined that his cobalt levels were elevated indicating metallosis.The patient was revised and allegedly during the procedure there was corrosion of the hardware resulting in permanent damage to surrounding tissues.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was described as an unknown accolade #5 hip stem.The information in this report was provided by stryker orthopaedics legal affairs.No additional information is available at this time due to ongoing litigation.Therefore, the exact cause of the event could not be determined because insufficient information available.

• Brand Name: UNKNOWN_CORK_PRODUCT
• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4765167
• MDR Text Key: 5777197
• Report Number: 0002249697-2015-01499
• Device Sequence Number: 1
• Product Code: MRA
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 05/12/2015
• 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