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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX HV US 1 PACK; BONE CEMENT
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STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX HV US 1 PACK; BONE CEMENT Back to Search Results
Catalog Number 6194-1-001
Device Problems Osseointegration Problem (3003); Insufficient Information (3190)
Patient Problems Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646)
Event Date 08/22/2018
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.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.
 
Event Description
It's alleged by the attorney, through the filing of a lawsuit, that the plaintiff underwent a right total knee arthroplasty (tka) on (b)(6) 2014 where simplex hv bone cement was utilized.It is further alleged that in (b)(6) 2018, bone scans found "increased uptake beneath tibial baseplate of right tka, concerning for loosening." the plaintiff underwent revision surgery on (b)(6) 2018.During this revision surgery, the surgeon confirmed the "tibial component was indeed grossly loose and easily extracted by hand.".
 
Manufacturer Narrative
An event regarding loosening involving simplex hv cement mix was reported.The event relates to product supplied by an oem.Method & results: device evaluation and results: not performed as the associated device is oem product.Medical records received and evaluation: 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 investigated by aap.Confirmation that an aap investigation has been initiated by the oem supplier site was received, and has been attached within the communication log.
 
Event Description
It's alleged by the attorney, through the filing of a lawsuit, that the plaintiff underwent a right total knee arthroplasty (tka) on (b)(6) 2014 where simplex hv bone cement was utilized.It is further alleged that in (b)(6) 2018, bone scans found "increased uptake beneath tibial baseplate of right tka, concerning for loosening." the plaintiff underwent revision surgery on (b)(6) 2018.During this revision surgery, the surgeon confirmed the "tibial component was indeed grossly loose and easily extracted by hand.".
 
Manufacturer Narrative
Updated the product information.Reported event: an event regarding loosening involving simplex hv cement mix was reported.The event relates to product supplied by an oem.Method & results: -device evaluation and results: not performed as the associated device is oem product.-medical records received and evaluation: 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 investigated by aap.Confirmation that an aap investigation has been initiated by the oem supplier site was received, and has been attached within the communication log.
 
Event Description
It's alleged by the attorney, through the filing of a lawsuit, that the plaintiff underwent a right total knee arthroplasty (tka) on (b)(6) 2014 where simplex hv bone cement was utilized.It is further alleged that in (b)(6) 2018, bone scans found "increased uptake beneath tibial baseplate of right tka, concerning for loosening." the plaintiff underwent revision surgery on (b)(6) 2018.During this revision surgery, the surgeon confirmed the "tibial component was indeed grossly loose and easily extracted by hand.".
 
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Brand Name
SIMPLEX HV US 1 PACK
Type of Device
BONE CEMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key9141869
MDR Text Key162439066
Report Number0002249697-2019-03355
Device Sequence Number1
Product Code LOD
Combination Product (y/n)N
PMA/PMN Number
K123225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 07/24/2020
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 Catalogue Number6194-1-001
Device Lot Number413AA857CV
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/05/2019
Initial Date FDA Received10/01/2019
Supplement Dates Manufacturer Received11/06/2019
06/25/2020
Supplement Dates FDA Received12/04/2019
07/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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