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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 Problems Break (1069); Fracture (1260)
Patient Problem Injury (2348)
Event Date 03/01/2018
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

The customer reported that the patient was revised following the fracture of a ceramic head.

 
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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
bradley curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7400807
MDR Text Key104525594
Report Number0002249697-2018-01013
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeGB
PMA/PMN NumberK052718
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 05/29/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6570-0-132
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/22/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2018
Was Device Evaluated By Manufacturer? Yes
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: 04/05/2018 Patient Sequence Number: 1
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