MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH STRYKER SIMPLEX HV BONE CEMENT; UNKNOWN HIP PRODUCT

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 11/04/2016

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.Stryker orthopaedics is a distributor of this device, which is manufactured by aap.Since the event reported resulted in an injury, per quality agreement, the distributor is reporting.The supplier has been notified.Product not returned.

Event Description

It is alleged by the attorney, through the filing of a lawsuit, that on (b)(6) 2014 hv bone cement was used on the plaintiff during a right tka.It is further alleged that the plaintiffs right knee had to be revised on (b)(6) 2016 due to mechanical loosening.

• Brand Name: STRYKER SIMPLEX HV BONE CEMENT
• Type of Device: UNKNOWN HIP PRODUCT
• 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: anna smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8106421
• MDR Text Key: 128431884
• Report Number: 0002249697-2018-03825
• Device Sequence Number: 1
• Product Code: LOD
• 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: 11/27/2018

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/27/2018
• 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