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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 Device Dislodged or Dislocated (2923); Material Deformation (2976)
Patient Problems Injury (2348); Joint Dislocation (2374)
Event Date 06/13/2018
Event Type  Injury  
Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

Dual mobility v40 ceramic head disassociated from the poly head. The patient felt acute instability while surfing, unable to continue. Called doctor and was advised to get an xray performed. On xray it became clear that the ceramic head was eccentric in the acetabulum and the poly was disassociated.

 
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Brand NameMODULAR DUAL MOBILITY INSERT
Type of DevicePROSTHESIS, 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
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7678569
MDR Text Key113688601
Report Number0002249697-2018-02138
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK103233
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/11/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number626-00-46F
Device LOT Number53276403
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/28/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/11/2018 Patient Sequence Number: 1
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