MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN CEMENT; BONE CEMENT

Catalog Number 6192-1-001

Device Problems Device Slipped (1584); Unstable (1667); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348)

Event Date 09/22/2011

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.

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 for: 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.

Manufacturer Narrative

An event regarding tibial baseplate loosening in the right knee involving an unknown bone cement was reported.The event was confirmed.Method and results: device evaluation and results: not performed as the product was not returned.Medical records received and evaluation: development of radiolucent lines at 6-months is very early and as such points to a very severe inadequate cementation of the baseplate.This relates to surgical technique and has no relationship with either bone cement, that has standardized properties, or the tibial baseplate device that has a standard surface understructure to serve optimal cemented fixation.The surgeon is responsible for quality of cementation as part of his surgical technique.This loss of fixation below the medial baseplate section contributes to micro-motion between cement and bone where it is known that micro-motion causes bone resorption.This process causes a self-accelerating downward spiral of progressive micro-motion and further progressive bone loss as evident in the progressive subsidence of the baseplate until complaints were so severe that revision was required after only some 2-years of implantation.Baseplate only cementation is the principal root cause of failure to provide suboptimal baseplate fixation with rapid disintegration of implant-bone interface and device subsidence requiring revision.Completely procedure-related event with minor secondary contribution by the patient overweight condition.Device history review: not performed as no device details were provided.Complaint history review: not performed as no device details were provided.Conclusions: medical review indicated that baseplate only cementation is the principal root cause of failure to provide suboptimal baseplate fixation with rapid disintegration of implant-bone interface and device subsidence requiring revision.Completely procedure-related event with minor secondary contribution by the patient overweight condition.No further investigation is possible at this time.If product details and additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

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 for: 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.

• Brand Name: UNKNOWN CEMENT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5238488
• MDR Text Key: 31677692
• Report Number: 0002249697-2015-03930
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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

• Date FDA Received: 11/20/2015
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2016
• 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