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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 41MM; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS
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STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 41MM; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS Back to Search Results
Catalog Number 6226-2-641
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/01/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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.
 
Event or Problem Description
It was reported that during a bipolar hip arthroplasty, the v40 head did not slide smoothly on the insert of the centrax.The surgeon implanted the devices as is.
 
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Brand Name
CENTRAX DURATION 26MM X 41MM
Common Device Name
HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7152361
Report Number0002249697-2017-03754
Device Sequence Number16398344
Product Code JDI
UDI-Device Identifier07613327032147
UDI-Public07613327032147
Combination Product (Y/N)N
PMA/510(K) Number
K972792
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date01/19/2022
Device Catalogue Number6226-2-641
Device Lot NumberR11W7K
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/04/2017
Initial Report FDA Received Date12/28/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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