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

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Unspecified Infection (1930); Injury (2348)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This pi is for revision done on (b)(6) 2019 due to pseudotumor and infection.Patient had a primary tha done at another facility.The implants that were implanted at this time received a recall.Patient had a revision tha done on 2019.The reason for this case was to remove the recalled implants.When the surgeon got into the capsule he found that the implants caused pseudotumor which in turn turned the tissue and cartridge to mush.Patient was brought back on 2019 for a second revision of the hip.A seroma occurred and became infected due to the recalled implants that caused the initial pseudotumor.The doctor thinks that when he opened the capsule the first time and found the pseudotumor from the implants it released the issues causing the seroma and in turn causing the overall function.The implants' recall/defectiveness were the overall causes of her issues.Nurse reported that not further information will be available.

• Brand Name: UNKNOWN STRYKER HIP
• 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: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8541766
• MDR Text Key: 142817578
• Report Number: 0002249697-2019-01690
• Device Sequence Number: 1
• Product Code: JDI
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/23/2019

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/23/2019
• 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