MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_SIMPLEX P SPEEDSET BONE CEMENT

Catalog Number UNK_LIM

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Ambulation Difficulties (2544)

Event Date 11/25/2018

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.

Event Description

This pi is for amputation.It was reported through the filing of a lawsuit that allegedly on or about (b)(6) 2016 the patient underwent a pkr of his left knee utilizing multiple components including the zimmer uni-compartmental knee system tibial component and articular surface femoral, smith & nephew uni oxonium femoral component and stryker speedset bone cement.Allegedly on or about (b)(6) 2018 he developed onset of pain in his left leg and calf and "ultrasound showed no flow in his popliteal artery distally and that he had a "foreign body that was impinging on his popliteal artery right at the tibial plateau." "ct angio confirmed a foreign body in the popliteal space and near complete occlusion of the popliteal artery at the level of the knee joint." he underwent surgery to remove bone cement and attempt revascularization of his leg.Allegedly the operating surgeon confirmed the object was bone cement that had likely "extruded from his initial operation has been sitting there" since that time.Unfortunately, by (b)(6) 2018 his leg had reoccluded and he underwent amputation for his left leg below the knee on (b)(6) 2018.

• Brand Name: UNKNOWN_SIMPLEX P SPEEDSET BONE CEMENT
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; IE NA
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10003382
• MDR Text Key: 189295876
• Report Number: 0002249697-2020-00810
• 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: 04/27/2020

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_LIM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2020
• Initial Date FDA Received: 04/27/2020
• 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): Disability