MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P SPEEDSET FULL DOSE 1 PACK; BONE CEMENT, ANTIBIOTIC

Catalog Number 6192-1-001

Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

It was reported via fda maude report number mw5056831: on (b)(6) 2010, right total knee replacement, stryker triathlon.On (b)(6) 2011 pain and instability, tibial component loosening.On (b)(6) 2012 right knee revision, stryker triathlon.Tibial component loosening of revision, cement failure.On (b)(6) 2013, implant loosening, cement failure to adhere, knee instability.On (b)(6) 2014, painful prosthesis, loosening.This pi is reporting: on (b)(6) 2013, implant loosening, cement failure to adhere, knee instability.On (b)(6) 2014, painful prosthesis, loosening.

Manufacturer Narrative

The following devices were also listed in this report: triathlon ps fem component, cemented; cat# 5515-f-502; lot# unknown; no 4.Triathlon ts plus tibial insert x3 poly 22mm; cat# 5537-g-422; lot# mhdpp8; tri ts baseplate size 4; cat# 5521-b-400; lot# hsxxd; tri cemented stem 12mmx50mm; cat# 5560-s-112; lot# m7m05l.Dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review confirmed that there have been no other similar events for the reported lot.The event was confirmed.Medical review indicated that this event has been discussed as related to cementation technique under revision surgery conditions which are related to surgical technique and thus are completely procedure related.

Event Description

It was reported via fda maude report number mw 5056831: on (b)(6) 2010, right total knee replacement, stryker triathlon.On (b)(6) 2011 pain and instability, tibial component loosening.On (b)(6) 2012 right knee revision, stryker triathlon.Tibial component loosening of revision, cement failure.On (b)(6) 2013,implant loosening, cement failure to adhere, knee instability.On (b)(6) 2014, painful prosthesis, loosening.This pi is reporting: on (b)(6) 2013,implant loosening, cement failure to adhere, knee instability.On (b)(6) 2014, painful prosthesis, loosening.

• Brand Name: SIMPLEX P SPEEDSET FULL DOSE 1 PACK
• 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
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5238520
• MDR Text Key: 31681298
• Report Number: 0002249697-2015-03943
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2015

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: 05/31/2014
• Device Catalogue Number: 6192-1-001
• Device Lot Number: DJT019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2012
• 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): Required Intervention