MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_SIMPLEX GHV BONE CEMENT; BONE CEMENT, ANTIBIOTIC

Catalog Number UNK_LIM

Device Problem Loss of Osseointegration (2408)

Patient Problem Insufficient Information (4580)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.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 osartis.The manufacturer has responsibility for regulatory decisions and mdr reporting.Supplier has been notified.Serious injury reports for hv products are also filed to the fda via stryker personnel.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient underwent a tka and during the procedure simplex ghv bone cement was utilized to cement all components in patient's knee.It is further alleged that on (b)(6) 2019 the patient underwent revision surgery and the tibial component was "completely loose".

• Brand Name: UNKNOWN_SIMPLEX GHV BONE CEMENT
• Type of Device: BONE CEMENT, ANTIBIOTIC
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12539400
• MDR Text Key: 273536869
• Report Number: 0002249697-2021-01632
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• 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: 719AA857CY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2021
• 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