MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX HV US PLAIN 10 PK; BONE CEMENT

Catalog Number 61941010

Device Problems Failure to Osseointegrate (1863); Insufficient Information (3190)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 07/22/2015

Event Type  Injury  

Manufacturer Narrative

An event regarding loosening involving a simplex hv cement mix was reported.Method & results: device evaluation and results: not performed as the associated device is oem product.Clinician review: 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.Written acknowledgement from the oem supplier that an investigation has been initiated at the oem supplier site was received.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.Device not returned.

Event Description

It was reported through the filing of a lawsuit that allegedly on (b)(6) 2014 the patient underwent a right sided total knee replacement using simplex hv bone cement.It is further alleged that on (b)(6) 2015 he had to undergo a revision surgery due to aseptic loosening.

Manufacturer Narrative

Reported event: an event regarding loosening involving a simplex hv cement mix was reported.Method & results: - device evaluation and results: not performed as the associated device is oem product.- clinician review: 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.Written acknowledgement from the oem supplier that an investigation has been initiated at the oem supplier site was received.

Event Description

It was reported through the filing of a lawsuit that allegedly on (b)(6) 2014 the patient underwent a right sided total knee replacement using simplex hv bone cement.It is further alleged that on (b)(6) 2015 he had to undergo a revision surgery due to aseptic loosening.Update june 16, 2020: device information and records received.The loose tibial component is competitor product.

• Brand Name: SIMPLEX HV US PLAIN 10 PK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9775887
• MDR Text Key: 185011206
• Report Number: 0002249697-2020-00440
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: K123225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

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 Expiration Date: 11/30/2018
• Device Catalogue Number: 61941010
• Device Lot Number: 333AB909GU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 07/05/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention