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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number 1236-2-852
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Injury (2348); Joint Dislocation (2374)
Event Date 11/26/2019
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
It was reported that the patient's left hip was revised. Patient suffered a disassociation (ceramic femoral head out of the adm/mdm poly insert), was closed reduced, dislocated and disassociated, with the femoral head articulating against the mdm metal liner (poly was both off the femoral head and out of the liner. Patient's poly insert and femoral head were revised. The rep may be able to obtain the explants for return, provided the primary usage sheet, and confirmed that no further information will be available.
 
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Brand NameRESTORATION ADM X3 INS 28/52
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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
collin neitzel
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9512976
MDR Text Key182943210
Report Number0002249697-2019-04096
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093644
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 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1236-2-852
Device Lot Number406640
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 Received11/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/28/2019
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: 12/23/2019 Patient Sequence Number: 1
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