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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P FULL DOSE 1 PACK; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
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STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P FULL DOSE 1 PACK; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT Back to Search Results
Catalog Number 6191-1-001
Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Fumes or Vapors (2529); Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2019
Event Type  malfunction  
Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other 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.Device not returned.
 
Event Description
It was reported that the box of cement was damaged and fumes were leaking from the box.Pictures of a single dose were provided showing damage to the corner of the box.Update per sales rep: "10pack was damaged with leaking monomer fluid.The account stated the box had been damaged and was leaking.Unsure if they were speaking about fumes leaking or liquid".Hospital disposed.1 box shipped.
 
Event Description
It was reported that the box of cement was damaged and fumes were leaking from the box.Pictures of a single dose were provided showing damage to the corner of the box.Update per sales rep: "10pack was damaged with leaking monomer fluid.The account stated the box had been damaged and was leaking.Unsure if they were speaking about fumes leaking or liquid".Hospital disposed.1 box shipped.
 
Manufacturer Narrative
Reported event: an event regarding pack damage involving simplex bone cement was reported.The event was confirmed based on the images provided.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a unit pack and 10 pack which show signs of liquid damage on the corners.There are no images available of the liquid or powder components.-clinician review: no medical records were received for review with a clinical consultant.-product history review: indicated all products were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: the reported device was not returned however photographs were provided for review.The photographs shows a unit pack and 10 pack which show signs of liquid damage on the corners.There are no images available of the liquid or powder components.Additional information received from the rep indicates "there the account stated that the box had arrived damaged and was filling their receiving dock with fumes".Based on the information provided, it appears that this product was damaged shortly before or during delivery.The liquid monomer from the ampoule lasts a short period of time as the liquid evaporates when exposed to the atmosphere.Based on the information provided, it appears that this product was damaged due to inappropriate handling during distribution/transportation.However, without images of the ampoule/pouch or product return, the root cause cannot be determined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
SIMPLEX P FULL DOSE 1 PACK
Type of Device
POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8463851
MDR Text Key140314486
Report Number0002249697-2019-01473
Device Sequence Number1
Product Code LOD
UDI-Device Identifier07613327128444
UDI-Public07613327128444
Combination Product (y/n)N
PMA/PMN Number
K062553
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 05/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2021
Device Catalogue Number6191-1-001
Device Lot NumberRKZ153
Was Device Available for Evaluation? No
Date Manufacturer Received04/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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