MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN C-TAPER LFIT FEMORAL HEAD; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Corroded (1131)

Patient Problems Inflammation (1932); Necrosis (1971); Discomfort (2330); Injury (2348); Reaction (2414); Ambulation Difficulties (2544)

Event Date 10/29/2016

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not returned.

Event Description

It was reported through the filing of a lawsuit that allegedly "just over one year after his tha, the patient began experiencing significant discomfort and stiffness in his left lateral hip".It is further alleged on "(b)(6) 2016 his serum cobalt level was 4.9 ng/ml and serum chromium was 1.1 ng/ ml; mars mri taken on (b)(6) 2016 showed effusion suspect for altr.Based upon these findings.He underwent partial revision surgery on (b)(6) 2016 at which the time the surgeon encountered severe tissue necrosis and black sludge corrosion at the trunnion interface".

• Brand Name: UNKNOWN C-TAPER LFIT FEMORAL HEAD
• Type of Device: HIP 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7970166
• MDR Text Key: 123865950
• Report Number: 0002249697-2018-03386
• Device Sequence Number: 1
• Product Code: KWY
• 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: 10/16/2018

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_JR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/16/2018
• 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): Hospitalization; Required Intervention