MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P - US FULL DOSE 10-PK; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT.

Catalog Number 61911010

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 03/14/2011

Event Type  Injury  

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

Patient called stating she had a right hip replacement done on (b)(6) 2009.Implant failed and patient was revised on (b)(6) 2011.

Event Description

Patient called stating she had a right hip replacement done on (b)(6) 2009.Implant failed and patient was revised on (b)(6) 2011.

Manufacturer Narrative

An event regarding a recall query involving simplex bone cement was reported.Conclusion: it was reported that patient is inquiring if his bone cement are part of a recall.As per product recall verification response, it is confirmed that the reported device is not subject to a recall.No further investigation is required at this time as no device failure modes or patient harms were identified in the reported event.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SIMPLEX P - US FULL DOSE 10-PK
• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8378854
• MDR Text Key: 137437197
• Report Number: 0002249697-2019-01219
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 37613327128445
• UDI-Public: 37613327128445
• Combination Product (y/n): N
• PMA/PMN Number: K062553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

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: 06/30/2014
• Device Catalogue Number: 61911010
• Device Lot Number: RAQ011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 05/31/2019
• Supplement Dates FDA Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 79