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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN BIOLOX C-TAPER HEAD HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN BIOLOX C-TAPER HEAD HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problem Material Discolored (1170)
Patient Problem Injury (2348)
Event Date 11/14/2018
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. Device not available.

 
Event Description

It was reported through the submission of a revision implant sheet that patient's left hip was revised. Rep notes on the implant sheet report "head exchange on an old howmedica stem. There was wear on the [competitor] liner, as well as a slight discoloration on the biolox c-taper head". Femoral head was revised to a 32 +5 c-taper lfit head.

 
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Brand NameUNKNOWN BIOLOX C-TAPER 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 NA
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8156389
MDR Text Key130097200
Report Number0002249697-2018-04008
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial
Report Date 12/12/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_SHC
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 Received11/14/2018
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: 12/12/2018 Patient Sequence Number: 1
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