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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 0 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 0 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 0580-1-352
Device Problems Sticking; Packaging Problem
Event Date 07/03/2017
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The customer reported that, as the scrub nurse peeled back the top film layer of the exeter stem package, the sterile packaging layer underneath was bonded to the top layer. The surgeon chose not to use this implant in case sterility had been breached. Another device was used to complete the case.

 
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Brand NameEXETER V40 STEM 37.5MM NO 0
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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
brian lauro
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key6755404
Report Number0002249697-2017-02342
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0580-1-352
Device LOT NumberG7035249
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/11/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/28/2017
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: 07/31/2017 Patient Sequence Number: 1
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