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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, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

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STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Model Number 626-00-46F
Device Problem Insufficient Information (3190)
Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870)
Event Date 08/24/2021
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 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
As reported: "revision of left acetabular component. Surgeon states patient is physically active and presented with pain and fracture of acetabulum. Surgeon states significant adverse local tissue reaction noted during surgery. Surgeon states cup was well fixed. " spoke to rep. Rep confirmed patient is very physically active (waterskiing, 72-hole golf, gym, etc). Intra-operatively, the surgeon confirmed that the mdm metal liner was well fixed and well positioned in the shell. Surgeon also confirmed there was no impingement on the femoral stem, and could not provide any possible cause or contributor to altr. A shell with dome hole plug, mdm metal liner, adm/ mdm poly insert, and v40 biolox ceramic head were revised. Rep confirmed there are no allegations against the revised poly insert or ceramic head. Rep provided imaging and primary implant report and confirmed that no further information will be released by the hospital or surgeon.
 
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Brand NameMODULAR DUAL MOBILITY INSERT
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
EI NA
Manufacturer Contact
marisol santiago
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12495369
MDR Text Key272151350
Report Number0002249697-2021-01572
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103233
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number626-00-46F
Device Catalogue Number626-00-46F
Device Lot Number65543504
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2018
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: 09/20/2021 Patient Sequence Number: 1
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