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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX TOBRAMYCIN 1 PK; BONE CEMENT
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STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX TOBRAMYCIN 1 PK; BONE CEMENT Back to Search Results
Catalog Number 61971001
Device Problems Insufficient Information (3190); Migration (4003)
Patient Problems Injury (2348); Ambulation Difficulties (2544)
Event Date 12/13/2019
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 two 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.Device not returned.
 
Event Description
A 44 no 2 exeter stem was revised due to subsidence.The surgeon stated it was not a failure of the implant, but that the bone / cement interface had failed, causing both the stem and cement mantle to subside.Surgeon was unable to provide details of primary surgery.
 
Event Description
A 44 no 2 exeter stem was revised due to subsidence.The surgeon stated it was not a failure of the implant, but that the bone / cement interface had failed, causing both the stem and cement mantle to subside.Surgeon was unable to provide details of primary surgery.
 
Manufacturer Narrative
An event regarding subsidence of a stem involving simplex cement mix was reported.The event was confirmed through clinician review of the provided x-ray.Method & results: device evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: first revision on (b)(6) 2014 for reported subsidence was not confirmed however, x-ray provided confirms revision on (b)(6) 2019 was due to subsided stem, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-device history review: indicated all ten packs were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been two other similar events for the lot referenced.The events relate to the same patient and are within this pi, therefore no additional trending is required.Conclusion: the event of subsidence was confirmed through clinician review of the provided x-ray.The exact cause of the event cannot be confirmed as insufficient information was provided.Additional information such as primary and revision operative reports, clinical and past medical history and additional serial dated x-rays are required to complete the investigation and determine a root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
SIMPLEX TOBRAMYCIN 1 PK
Type of Device
BONE CEMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key9608332
MDR Text Key188388096
Report Number0002249697-2020-00137
Device Sequence Number1
Product Code LOD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 03/03/2020
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 Expiration Date03/31/2016
Device Catalogue Number61971001
Device Lot NumberTFV026
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/23/2019
Initial Date FDA Received01/20/2020
Supplement Dates Manufacturer Received02/04/2020
Supplement Dates FDA Received03/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age68 YR
Patient Weight84
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