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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OSTEONICS C-TAPER ZIRCONIA HD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

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STRYKER ORTHOPAEDICS-MAHWAH OSTEONICS C-TAPER ZIRCONIA HD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU Back to Search Results
Catalog Number 16-3205
Device Problems Break (1069); Fracture (1260)
Patient Problems Failure of Implant (1924); Injury (2348)
Event Date 02/23/2018
Event Type  Injury  
Manufacturer Narrative

An event regarding fracture involving an alumina ceramic head was reported. A review of the provided explant photographs and x-rays by a clinical consultant confirmed the event. Method and results: device evaluation and results: not performed as product was not returned, however an image of the explanted device was made available. The explant photographs confirm the fractured ceramic parts. Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated adequate component positioning. Device history review: could not be performed as lot code information was not provided. Complaint history review: could not be performed as lot code information was not provided. Conclusions: a medical review of the ceramic head was conducted on explant photographs, which showed the fracture of the ceramic parts. X-rays appear to reveal adequate component position. As there is no other clinical or imaging information, the cause of the fracture can not be solved with current information. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

It was reported that patient's hip was revised due to a failed implant. A shattered ceramic femoral head and a liner were revised.

 
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Brand NameOSTEONICS C-TAPER ZIRCONIA HD
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
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 Key7359456
MDR Text Key103100149
Report Number0002249697-2018-00838
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK925695
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 05/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number16-3205
Device LOT NumberUNKNOWN
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 Received04/03/2018
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
Removal/Correction Number2243265-08/16/01-003R

Patient TREATMENT DATA
Date Received: 03/21/2018 Patient Sequence Number: 1
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