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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS Back to Search Results
Catalog Number 626-00-46F
Device Problems Mechanics Altered (2984); Insufficient Information (3190)
Patient Problems Injury (2348); Joint Dislocation (2374)
Event Date 07/15/2015
Event Type  Injury  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was reported that the surgeon notice the dislocation of the liner just after the operation from the x-ray.So, he made an incision again just after the operation and tried to lock the same liner again and again, but it could not be locked properly.New liner was used instead of it and the new liner could be locked.
 
Manufacturer Narrative
An event regarding seating/locking issues and dislocation (disassociation) involving an mdm liner was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection: the device was unremarkable.Dimensional inspection: the device was dimensionally inspected and confirmed to meet specification requirements (ref.Attached inspection) functional inspection: a functional inspection was carried out as per modular dual mobility acetabular system surgical technique, with the returned mdm liner and an in-house trident hemispherical cluster shell (502-01-58f).The devices assembled successfully and passed functional inspection.-medical records received and evaluation: a medical review was not performed because insufficient information was provided.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there has been one other event for the reported lot.Conclusions: the exact cause of the event could not be determined because the device was dimensionally and functionally within specification.If additional information becomes available, this investigation will be reopened.
 
Event Description
It was reported that the surgeon notice the dislocation of the liner just after the operation from the x-ray.So, he made an incision again just after the operation and tried to lock the same liner again and again, but it could not be locked properly.New liner was used instead of it and the new liner could be locked.On 08/19/2015: it was confirmed that the issue was with the mdm metal liner, 626-00-46f not locking into the cup, 508-11-58f, lot 49973401.
 
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Brand Name
MODULAR DUAL MOBILITY INSERT
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5001614
MDR Text Key22903415
Report Number0002249697-2015-02637
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103233
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Followup
Report Date 07/15/2015
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 Date03/31/2020
Device Catalogue Number626-00-46F
Device Lot Number51259604
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/13/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/20/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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