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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 Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 02/19/2018
Event Type  Injury  
Manufacturer Narrative
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.(b)(4) is a distributor of this device, which is manufactured by aap.Since the event reported resulted in an injury, per quality agreement, the distributor is reporting.The supplier has been notified.Product not returned.
 
Event Description
It is alleged by the attorney, through the filing of a lawsuit, that on (b)(6) 2015 simplex hv bone cement was used on the plaintiff during a right tka.It is further alleged that the plaintiff's right knee had to be revised on (b)(6) 2018 due to loosening.
 
Manufacturer Narrative
Corrected date: manufacturing site for devices.An event regarding loosening involving simplex hv cement 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.
 
Event Description
It is alleged by the attorney, through the filing of a lawsuit, that on (b)(6) 2015 simplex hv bone cement was used on the plaintiff during a right tka.It is further alleged that the plaintiff's right knee had to be revised on (b)(6) 2018 due to loosening.
 
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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 Key8107722
MDR Text Key128470428
Report Number0002249697-2018-03826
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
Report Date 01/14/2019
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 Catalogue Number6194-1-001
Device Lot Number521AAB54DW
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/29/2018
Initial Date FDA Received11/27/2018
Supplement Dates Manufacturer Received12/17/2018
Supplement Dates FDA Received01/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
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