MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P SPEEDSET FULL DOSE 1 PACK; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT.

Catalog Number 6192-1-001

Device Problems Loss of or Failure to Bond (1068); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 09/01/2010

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 however, the patient stated they had legal representation therefore, due to the ongoing litigation, no additional information is available at this time.If additional information is received it will be reported on a supplemental report.

Event Description

It was reported via fda maude report number mw 5055985: need to wear knee brace for support.Had both knees replaced in 2010.Within one year, right knee needed to be replaced because of cement failure.During the revision, the cement set up too fast, so doctor hammered the stump in, so i have x-rays and doctor reports showing loosening.The stump was never tight in the socket as it should be.I can feel joint move as i walk.I need to wear a brace for support.Left knee is now also loosened up and needs to be replaced.The cement is designed to last 20 years as per doctor but doctor conveniently forgot to document on my medical report.Lawyer (b)(6) has all test and doctors' reports.(b)(6).This pi is for need to wear knee brace for support.Had both knees replaced in 2010.Within one year, right knee needed to be replaced because of cement failure.

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.As per medical review, the devices added to the product grid did not contribute to the patient's experience.This event is being reported for ligament issues resulting in the necessity of the patient to wear a brace.This is a procedure-related event.An event regarding instability and ligament issues in the right knee following revision surgery where the patient is wearing a brace involving simplex speedset bone cement was reported.The event was confirmed.Method & results: -device evaluation and results: not performed as the product was not returned as it remains implanted.-medical records received and evaluation: fact remains that clinical symptoms of pain recurred rather soon after revision surgery while on x-ray baseplate stability became marginal with radiolucent lines around most of the proximal baseplate section and the distal stem still relatively well anchored in the tibial diaphysis.This baseplate is certainly not (yet) grossly loose and thus is the decision of the second opinion surgeon not to revise again quite understandable.There currently is a far from ideal condition of the knee but the proper question would be whether repeat revision surgery would improve the patient¿s condition significantly, this answer is probably no.A major bone defect condition, now filled with bone cement, would have to be addressed with major bone grafting and large metallic devices, likely at least a hinged knee and possibly even gmrs types of devices.These are major undertakings with significant risk on complications or infection which would destroy any benefit for the patient.The second opinion surgeon reported the knee also suffered from ligamentous instability with joint line level issues.These are not very well specified in the records and very much dependent upon findings during physical examination of the knee as related to soft tissue structures around the knee that are not visible on x-ray.We will take this message of ligamentous instability which was the reason this surgeon prescribed a knee brace to support the knee ligament stability because surgery was no option at this time.The prescription of a knee brace thus relates to the end stage of problems in this failed right revision knee that cannot be addressed at this time with repeat revision surgery.Conservative measures as with knee brace plus pain medication remain as only viable options to benefit the patient even though not with satisfactory clinical success, at least on a subjective level for the patient.Because all previous failure factors are procedure related in principal root cause, also this knee brace prescription falls in the same category of procedure-related matters in the failure scenario of the right knee.-device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.-complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: during revision surgery for loosening of the primary baseplate it is reported that the cement set up too fast and that the surgeon had to hammer the implant in and an intraoperative fracture occurred (pi).Subsequently loosing of the revision implant was reported (pi) and also instability and ligament issues resulting in the necessity of the patient to wear a brace (this pi).Medical review indicated end stage failure of right knee as a consequence of all principal procedure-related failure factors of previous events in right knee.No repeat revision surgery options are possible and therefore brace with pain medication is only possible relief.This is a procedure-related event.No further investigation is possible at this time.If 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 mw5055985: need to wear knee brace for support.Had both knees replaced in 2010.Within one year, right knee needed to be replaced because of cement failure.During the revision, the cement set up too fast, so doctor hammered the stump in, so i have x-rays and doctor reports showing loosening.The stump was never tight in the socket as it should be.I can feel joint move as i walk.I need to wear a brace for support.Left knee is now also loosened up and needs to be replaced.The cement is designed to last 20 years as per doctor but doctor conveniently forgot to document on my medical report.Lawyer (b)(6) has all test and doctors' reports.(b)(6).This pi is for need to wear knee brace for support.Had both knees replaced in 2010.Within one year, right knee needed to be replaced because of cement failure.

• Brand Name: SIMPLEX P SPEEDSET FULL DOSE 1 PACK
• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) 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: 5238489
• MDR Text Key: 31676717
• Report Number: 0002249697-2015-03935
• 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

• 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: DJT019
• 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