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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN PCA HIP STEM HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN PCA HIP STEM HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problem Loss of Osseointegration (2408)
Patient Problems Bone Fracture(s) (1870); Injury (2348); Inadequate Osseointegration (2646)
Event Date 04/10/2018
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Not returned.
 
Event Description
It was reported through the submission of a revision implant sheet that patient's right hip was revised. As reported by rep: "patient had a loose pca stem. Surgeon revised to a distal fixated stem and changed liner". Revision implants were a restoration modular hip stem and neck, insert, femoral head, and 4 cables. Update 27 april, 2018: rep has responded stating that there was a periprosthetic fracture of the proximal femur.
 
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Brand NameUNKNOWN PCA HIP STEM
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
bradley curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7493558
MDR Text Key107559574
Report Number0002249697-2018-01353
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 health professional,other
Reporter Occupation
Type of Report Initial
Report Date 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_JR
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 Received04/10/2018
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: 05/08/2018 Patient Sequence Number: 1
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