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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTPILLAR TMZF SIZE 6 LEFT HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH CENTPILLAR TMZF SIZE 6 LEFT HIP IMPLANT Back to Search Results
Catalog Number 5353-0-106
Device Problems Material Deformation; Noise, Audible
Event Date 05/17/2018
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation. Additional information has been requested. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. The event involves a device that is not cleared for sale in the u. S. , but similar device is commercially available in the u. S.

 
Event Description

The patient underwent tha surgery with centpillar on (b)(6) 2009. The patient claimed abnormal sound from the left hip and a dislocation of the metal head was confirmed. Revision surgery was performed on (b)(6) 2018, and an insert, the metal head and the stem were replaced. Wear of the stem neck was noticed. Also, inside of the patient's hip joint was black by metal abrasion powder.

 
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Brand NameCENTPILLAR TMZF SIZE 6 LEFT
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
keyla colon
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key7597101
Report Number0002249697-2018-01799
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5353-0-106
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/06/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2018
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: 06/13/2018 Patient Sequence Number: 1
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