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

Catalog Number 6195-1-001

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding loosening involving simplex hv cement was reported.The event relates to product supplied by an oem.Method & results: device evaluation and results: not performed as the associated device is oem product.Medical records received and evaluation: not performed as the associated device is oem product.Device history review: not performed as the associated device is oem product.Complaint history review: not performed as the associated device is oem product.Conclusions: the reported device is an oem product investigated by aap.Confirmation that an aap investigation has been initiated by the oem supplier site was received, and has been attached within the communication log.Device not returned.

Event Description

It was reported by the attorney, through the filing of a lawsuit, that the plaintiff underwent a right total knee arthroplasty.It is further alleged that the plaintiff was later revised due to mechanical loosening of her knee components, and debonding of the simplex hv bone cement.

• 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
• Manufacturer Contact: anna smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8157899
• MDR Text Key: 130161147
• Report Number: 0002249697-2018-04024
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2018

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: 6195-1-001
• Device Lot Number: 448BC963JV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/12/2018
• 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
• Patient Age: 59 YR