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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 2 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 2 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 0580-1-372
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/22/2017
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

According to the surgeon, one of the prongs on the spigot protector was bent when the prosthesis was unpacked. It was therefore not possible to attach it to the stem introducer, so the prosthesis was positioned by hand. There were no adverse consequences and it did not affect the outcomes the surgery.

 
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Brand NameEXETER V40 STEM 37.5MM NO 2
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-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
timothy rice
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6963514
MDR Text Key90667093
Report Number0002249697-2017-03068
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeNO
PMA/PMN NumberK121308
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/16/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0580-1-372
Device LOT NumberG7153667
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/22/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/24/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/19/2017 Patient Sequence Number: 1
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