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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN CERAMIC HEAD HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN CERAMIC HEAD HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problem Break (1069)
Patient Problems Fall (1848); Injury (2348)
Event Date 01/31/2018
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Not returned.

 
Event Description

The surgeon reported that the patient presented following a fall. Upon x-ray it was noticed that the ceramic head had shattered. The patient was revised on (b)(6) 2018.

 
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Brand NameUNKNOWN CERAMIC HEAD
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NJ NA
Manufacturer Contact
timothy rice
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7304403
MDR Text Key101231076
Report Number0002249697-2018-00578
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeGB
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 04/12/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_JR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 02/28/2018 Patient Sequence Number: 1
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