MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX HV WITH GENTAMICIN US 1 PACK; BONE CEMENT

Model Number 6195-1-001

Device Problem Insufficient Information (3190)

Patient Problem Joint Laxity (4526)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

Stryker orthopaedics is a distributor of this device, which is manufactured by osartis.The manufacturer has responsibility for regulatory decisions and mdr/mdv reporting.Supplier has been notified.Serious injury reports for hv products are also filed to the fda via stryker personnel.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It was reported by the patient's attorney as a result of a legal claim that allegedly on (b)(6) 2015 the patient underwent a right total knee arthroplasty using simplex hv bone cement with gentamicin.It is further alleged that on (b)(6) 2019 he had to undergo a revision surgery due to loose tibia and marked instability.

• Brand Name: SIMPLEX HV WITH GENTAMICIN US 1 PACK
• 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 ; EI NA
• Manufacturer Contact: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10799780
• MDR Text Key: 215035874
• Report Number: 0002249697-2020-02353
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 04260056885761
• UDI-Public: 04260056885761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2020

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 Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-001
• Device Lot Number: 442BA870DV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/06/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR