MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE STEM; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Corroded (1131)

Patient Problems Pain (1994); Seroma (2069); Weakness (2145); Injury (2348); Reaction (2414)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that a revision was performed on a left total hip due to pain and weakness in the hip.Doctor noted that when opening patient's hip, he immediately found large amounts of fluid and abnormal tissue which were both sent on to pathology (pathology identified the abnormal tissue as a pseudo-tumor).Doctor also stated that there was corrosion inside the femoral head and on the trunnion, and that the levels of chromium and cobalt were elevated.Doctor cleaned the trunnion and applied a new sleeve over the trunnion with a delta head and an mdm liner & insert.There were no delays in surgery.

• Brand Name: UNKNOWN ACCOLADE STEM
• Type of Device: 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6736366
• MDR Text Key: 80810617
• Report Number: 0002249697-2017-02264
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2017
• 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
• Patient Age: 76 YR
• Patient Weight: 84