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

Catalog Number UNK_SHC

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Pain (1994); Injury (2348); Osteolysis (2377)

Event Date 03/23/2017

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 through the filing of a lawsuit that allegedly approximately 7 years after her total hip arthroplasty, patient began experiencing significant left hip pain and discomfort.Upon mri evaluation, a left hip pseudotumor was discovered.It is further alleged that during revision surgery on (b)(6) 2016 surgeon encountered a pseudotumor, significant metallosis inside the hip joint, trunnionosis around the implant and osteolysis around the proximal femur.The lfit v40 cobalt chrome head was removed and replaced with a ceramic head.

• Brand Name: UNKNOWN ACCOLADE TMZF PLUS FEMORAL 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: sarah smelko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6503717
• MDR Text Key: 73219421
• Report Number: 0002249697-2017-01294
• Device Sequence Number: 1
• Product Code: JDG
• 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: 04/19/2017

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: 03/23/2017
• Initial Date FDA Received: 04/19/2017
• 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