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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P-JAPANESE TWIN PACK; BONE CEMENT
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STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P-JAPANESE TWIN PACK; BONE CEMENT Back to Search Results
Catalog Number 61910002
Device Problems Device Difficult to Setup or Prepare (1487); Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 05/28/2020
Event Type  malfunction  
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.
 
Event Description
Artificial head surgery after nail removal.Use exeter long.I tried to inject the cement, but about 5 minutes after the start of stirring, the cement became hard and could not be injected.I tried to insert a stem (exeter 37.5 long) without pressure raising the medullary cavity, but the cement was hard and the stem could not be inserted at all.The cement had hardened in the medullary cavity.The surgery was successfully completed by excavating the cement a little and inserting a 35.5 exeter as in the cement-in-cement method.There were no problems with postoperative alignment or joint tension.Physician's comment: amikacin may be added too much as a cause of the event.(10 vials for 80g).Update: surgical delay: 120 min, left side.
 
Manufacturer Narrative
Reported event an event regarding setting time involving a simplex cement mix was reported.The event was not confirmed.Method & results -product evaluation and results: visual inspection was performed while mixing the cement product.No unusual characteristics were observed during the mixing.It was also stated that the samples 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.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the cement hardened too quickly, while the exact setting time recorded and how the setting time recorded were not reported.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.Thus, the reported event is not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as the exact setting time recorded and how the setting time recorded are needed to complete the investigation for determining 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.
 
Event Description
Artificial head surgery after nail removal.Use exeter long.I tried to inject the cement, but about 5 minutes after the start of stirring, the cement became hard and could not be injected.I tried to insert a stem (exeter 37.5 long) without pressure raising the medullary cavity, but the cement was hard and the stem could not be inserted at all.The cement had hardened in the medullary cavity.The surgery was successfully completed by excavating the cement a little and inserting a 35.5 exeter as in the cement-in-cement method.There were no problems with postoperative alignment or joint tension.Physician's comment: amikacin may be added too much as a cause of the event.(10 vials for 80g) update: surgical delay: 120 min, left side.
 
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Brand Name
SIMPLEX P-JAPANESE TWIN PACK
Type of Device
BONE CEMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key10161994
MDR Text Key195390757
Report Number0002249697-2020-01213
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 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2023
Device Catalogue Number61910002
Device Lot NumberJHA036
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/28/2020
Initial Date FDA Received06/17/2020
Supplement Dates Manufacturer Received11/11/2020
Supplement Dates FDA Received12/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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