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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/0 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

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STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/0 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS Back to Search Results
Catalog Number 6570-0-132
Device Problem Device Operates Differently Than Expected
Event Date 02/19/2018
Event Type  Malfunction  
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. A supplemental report will be submitted upon completion of the investigation.

 
Event Description

It was reported that in performing a primary hip (side not reported) procedure, the 32mm +0 head would not lock onto the accolade ii stem. The head was able to be manually removed by the surgeon. Another head was immediately available and locked onto the stem with no issues. Rep reported that no case time was lost (no surgical delay).

 
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Brand NameDELTA V-40 CERAMIC HEAD 32/0
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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
juana hiciano
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key7342834
Report Number0002249697-2018-00764
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6570-0-132
Device LOT Number62189001
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/27/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/09/2017
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: 03/15/2018 Patient Sequence Number: 1
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