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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNI ADAPTOR SLEEVE V40 TI PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

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STRYKER ORTHOPAEDICS-MAHWAH UNI ADAPTOR SLEEVE V40 TI PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS Back to Search Results
Catalog Number 6519-T-204
Device Problems Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem
Event Date 08/28/2017
Event Type  Malfunction  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

It was reported that, during a tha, the trunnion sleeve did not fit completely (there was a gap) on the stem trunnion (citation stem).

 
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Brand NameUNI ADAPTOR SLEEVE V40 TI
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
timothy rice
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key6903193
Report Number0002249697-2017-02888
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6519-T-204
Device LOT Number55745304
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/03/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/09/2016
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: 09/29/2017 Patient Sequence Number: 1
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