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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 42MM OSTEONICS SHELL HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH 42MM OSTEONICS SHELL HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problems Migration or Expulsion of Device (1395); Loss of Osseointegration (2408)
Patient Problem Injury (2348)
Event Date 12/07/2016
Event Type  Injury  
Manufacturer Narrative
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
This report is for revision of primary left hip. In reporting a revision of patient's left hip on (b)(6) 2018, rep reported that the patient had been previously revised on (b)(6) 2016 at an out-of-state facility for reasons unknown. A competitor shell and stryker femoral head (liner manufacturer unknown) were revised to a competitor shell with a stryker mdm/adm liner construct, ceramic head, and adapter sleeve. Rep will be providing a 'patient packet' for the 2018 revision, and has no access to the out-of-state facility's records. As per information received via an operative report, revision was due to failed acetabular component - originally noted to be a competitor device, the hip construct was comprised of all stryker devices. As reported: ". We noted the acetabular component had a complete poly wear through in the posterior superior quadrant. There was also a slightly retroverted orientation of the acetabular component. There was noted to be several areas of osteolysis. ".
 
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Brand Name42MM OSTEONICS SHELL
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
merin grace
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7588004
MDR Text Key110646928
Report Number0002249697-2018-01762
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_JR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/11/2018 Patient Sequence Number: 1
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