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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH STD, LT HUMERAL ASSEMBLY; ELBOW JOINT METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS.
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STRYKER ORTHOPAEDICS-MAHWAH STD, LT HUMERAL ASSEMBLY; ELBOW JOINT METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS. Back to Search Results
Catalog Number 5005-002L
Device Problems Naturally Worn (2988); Insufficient Information (3190)
Patient Problems Injury (2348); Osteolysis (2377); No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2016
Event Type  Injury  
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
On (b)(6) 2012, solar elbow primary surgery was performed.And the revision surgery was performed on (b)(6) 2015.Terrible osteolysis was found on the affected area.The polyethylene parts are worn.The axis and the polyethylene parts were replaced and finished the surgery.
 
Manufacturer Narrative
The device was not returned for evaluation.An event regarding osteolysis involving a solar stem was reported.The event was not confirmed.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, pre- and post-op xrays, patient history, histopathology report and follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
 
Event Description
On (b)(6) 2012, solar elbow primary surgery was performed.And the revision surgery was performed on (b)(6) 2015.Terrible osteolysis was found on the affected area.The polyethylene parts are worn.The axis and the polyethylene parts were replaced and finised the surgery.
 
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Brand Name
STD, LT HUMERAL ASSEMBLY
Type of Device
ELBOW JOINT METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS.
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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5761241
MDR Text Key48518498
Report Number0002249697-2016-02129
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
K980502
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number5005-002L
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/31/2016
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
Patient Weight50
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