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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA C-TAPER HEAD 28MM/0 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

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STRYKER ORTHOPAEDICS-MAHWAH ALUMINA C-TAPER HEAD 28MM/0 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS Back to Search Results
Catalog Number 17-2800E
Device Problems Break (1069); Noise, Audible (3273)
Patient Problem Injury (2348)
Event Date 03/06/2018
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.
 
Event Description
The patient underwent tha surgery with alumina c-taper head 28 mm 10 years ago. Recently, she heard a sound of the alumina c-taper head breaking. On (b)(6) 2018, revision surgery was performed and the aumina c-taper head and alumina ceramic liner were replaced. Since there are no injuries such as falls in the patient, the cause of the breakage is unknown.
 
Manufacturer Narrative
An event regarding crack/fracture involving a ceramic head was reported. The event was confirmed through material analysis. Visual inspection:visual inspection was performed as part of the material analysis report (mar). The returned devices were examined with the aid of a stereo microscope at magnifications up to 50x. Approximately 85% of the ceramic head was returned. The ceramic head fragments were observed to have metal transfer marks, post fracture chipping and abrasion. Macroscopic analysis of the fracture surface indicated that the head likely fractured due to hoop stresses. A continuous metal transfer ring was not observed on the proximal end of the internal circumference of the female taper. The presence of a continuous metal transfer ring is consistent with proper seating between the trunnion of the hip stem and the head taper. Dimensional inspection: not performed due to a material integrity issue as there is evidence from the visual inspection that the device is damaged. Functional inspection: not performed due to a material integrity issue as there is evidence from the visual inspection that the device is damaged. A material analysis has been performed. The report concluded: the ceramic head fragments were observed to have post fracture chipping, and abrasion. The head likely fractured due to hoop stresses. A continuous metal transfer ring was not observed on the proximal end of the internal circumference of the female taper. The damages observed on the metal sleeve were consistent with contact with the ceramic head fragments. Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined. No medical records were received for review with a clinical consultant 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. The exact cause of the event could not be determined because insufficient information was provided. Additional information, including operative reports, progress notes and x-rays are needed to fully investigate the event. If further information becomes available this investigation will be re-opened.
 
Event Description
The patient underwent tha surgery with alumina c-taper head 28mm 10 years ago. Recently, she heard a sound of the alumina c-taper head breaking. On (b)(6) 2018, revision surgery was performed and the aumina c-taper head and alumina ceramic liner were replaced. Since there are no injuries such as falls in the patient, the cause of the breakage is unknown.
 
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Brand NameALUMINA C-TAPER HEAD 28MM/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
juana hiciano
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7390319
MDR Text Key104108886
Report Number0002249697-2018-00943
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
K971409
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 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number17-2800E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2018
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: 04/02/2018 Patient Sequence Number: 1
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