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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA C-TAPER HEAD 36MM/0 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

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STRYKER ORTHOPAEDICS-MAHWAH ALUMINA C-TAPER HEAD 36MM/0 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS Back to Search Results
Catalog Number 17-3600E
Device Problems Migration or Expulsion of Device (1395); Noise, Audible (3273)
Patient Problems Unspecified Infection (1930); Pain (1994); Injury (2348)
Event Date 09/12/2003
Event Type  Injury  
Manufacturer Narrative
An event regarding infection, pain and audible noise involving a trident alumina liner was reported. The event for infection was not confirmed however, audible noise was confirmed by medical review. Method & results: product evaluation and results: not performed as the device was not returned. Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: "on (b)(6) 2003 he underwent a primary right total hip arthroplasty for a diagnosis of osteoarthritis of the right hip. " [. ] "an office visit of (b)(6) 2003 notes the patient to be "doing well". When seen on (b)(6) 2003 he was allowed weightbearing as tolerated and was to return in two months. He was seen on (b)(6) 2003 in the emergency room where it was noted, "hip started popping. Seems like sciatic pain". "" [. ] "he had a consultation on (b)(6) 2011 where it was noted, "failing ceramic right total hip arthroplasty. Acetabular component may be too flat and is causing impingement which has led to. Squeaking and probable ceramic failure. Getting stiffer. More pain. Plan: revision". On (b)(6) 2011 a revision of the right acetabulum was performed for a diagnosis of painful right total hip arthroplasty. The operative report describes spinal anesthesia and use of the previous posterolateral approach. At surgery an anterior hip impingement with a retroverted acetabular component was noted. The alumina head had "one small area of striping; otherwise, normal". " [. ] "x-ray printouts available for review include a series dated (b)(6) 2011, which is an ap of a right uncemented total hip arthroplasty, which is reduced. A radiodense, large head is noted and the components are in nominal position. " [. ] "while no pre-op x-rays are available for review, the revising surgeon noted malposition of the acetabular component of the primary total hip arthroplasty resulted in impingement and subluxation of the ceramic-ceramic bearing with a single stripe wear noted on the alumina head. These factors have been described as associated with increased incidence of squeaking in ceramic-ceramic hip arthroplasties. This may be relevant in this case. " product history review: a device history review confirmed all devices accepted into finished goods conformed to specification. Complaint history review: there has been one other event for audible noise for the lot indicated and no other infection events were reported for the lot and sterile lot indicated. Conclusions: the reported event of infection could not be confirmed as insufficient information was provided. A trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting. Audible noise was confirmed due to malposition of the shell which "resulted in impingement and subluxation of the ceramic-ceramic bearing with a single stripe wear noted on the alumina head. " the consulting clinician indicated, "these factors have been described as associated with increased incidence of squeaking in ceramic-ceramic hip arthroplasties. " stryker orthopaedics conducted an investigation to evaluate reports of audible noise during motion involving trident ceramic bearing systems. An analysis of the overall complaint data, and additional information concerning this evaluation was completed. Stryker orthopaedics determined that the root cause of squeaking is associated with repetitive edge loading of the femoral bearing against the edge of the ceramic insert. Edge loading, the mechanism by which a wear scar (stripe wear) is generated on the ceramic bearing surfaces, is primarily associated with impingement, joint laxity, and implant orientation. Stryker orthopaedics created separate and distinct surgical techniques, one for the trident psl shell and one for the trident hemispherical shell in order to clarify the different reaming techniques recommended to achieve initial fixation. In addition, language was added to instruct users to check shell position/orientation and to assess impingement during range of motion checks. No further investigation for this event is possible at this time. If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened. Device not returned.
 
Event Description
It was reported through the filing of a lawsuit, that allegedly the patient received a trident ceramic acetabular system. It is alleged that patient "has suffered and continues to suffer both injuries and damages, including but not limited to: past, present and future physical and metal pain and suffering and extraordinary loosening and infection. As a result of the implantation of the device, the patient required a revision surgery on (b)(6) 2011. Update as per medical review: clinician concluded, "while no pre-op x-rays are available for review, the revising surgeon noted malposition of the acetabular component of the primary total hip arthroplasty resulted in impingement and subluxation of the ceramic-ceramic bearing with a single stripe wear noted on the alumina head. ".
 
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Brand NameALUMINA C-TAPER HEAD 36MM/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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7556779
MDR Text Key109645684
Report Number0002249697-2018-01649
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K991952
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2008
Device Catalogue Number17-3600E
Device Lot Number5581703
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2003
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: 05/31/2018 Patient Sequence Number: 1
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