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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 Device Difficult to Setup or Prepare (1487); Use of Device Problem (1670)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2020
Event Type  malfunction  
Manufacturer Narrative
The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.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.Device not returned.
 
Event Description
The customer reported that when mixing the simplex cement, it set in approximately 4 minutes meaning some cement was stuck in the femur before the stem could be inserted.They then had to mix another mix of cement and use a shorter stem than originally planned.Delay of approximately 20 minutes.
 
Event Description
The customer reported that when mixing the simplex cement, it set in approximately 4 minutes meaning some cement was stuck in the femur before the stem could be inserted.They then had to mix another mix of cement and use a shorter stem than originally planned.Delay of approximately 20 minutes.
 
Manufacturer Narrative
Reported event: an event regarding setting time involving a simplex cement mix was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection was performed on three of the retain samples of the reported lot while mixing the cement product.No unusual characteristics were observed during the mixing.It was also stated that the cement was seen to have a homogeneous appearance.Functional testing was performed on three of the retain samples of the reported lot to verify the doughing time, working time and setting time of the product.The laboratory report show that the samples met the required specification for the test.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that the hospital felt the simplex product setting time was quicker than anticipated setting time.The event was not confirmed.Visual inspection was performed on three of the retain samples of the reported lot while mixing the cement product.No unusual characteristics were observed during the mixing.It was also stated that the cement was seen to have a homogeneous appearance.Functional testing was performed on three of the retain samples of the reported lot to verify the doughing time, working time and setting time of the product.The laboratory report show that the samples met the required specification for the test.The exact cause of the event could not be determined because insufficient information was provided.Additional information including details of mixing technique, storage and using environment and return of the product are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not returned.
 
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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 Key10699507
MDR Text Key211950267
Report Number0002249697-2020-02177
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
Type of Report Initial,Followup
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
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 Number61971001
Device Lot NumberTMA054
Was Device Available for Evaluation? No
Date Manufacturer Received11/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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