MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 36/0 ALUMINA INSERT; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Noise, Audible (3273)

Patient Problem Injury (2348)

Event Date 03/26/2012

Event Type  Injury  

Manufacturer Narrative

An event regarding audible noise involving an unknown liner was reported.The event was confirmed.Method & results: device evaluation and results: not performed as no product was performed.Medical records received and evaluation: a review of the primary and revision operative reports and office notes by the consulting clinician indicated "x-ray printouts include a series dated march 20, 2007, which is an ap of the pelvis and lateral of the right hip, demonstrating an uncemented total hip arthroplasty with no screws in the acetabulum.An alumina head is noted on the femoral component and the hip is reduced.The stem is in nominal position, but the acetabulum is noted to be slightly vertical at approximately 60°." "there is no examination of the explanted components available.There has been a reported increased incidence of squeaking in ceramic-ceramic hip arthroplasties in which the acetabular component is placed in a more vertical position than nominal.This may be relevant in this case." device history review could not be performed as the device details are unknown.Complaint history review could not be performed as the device details are unknown.Conclusions: the reported event was confirmed.However, the exact cause of the event could not be determined because insufficient information was provided.A review of the primary and revision operative reports and office notes by the consulting clinician indicated "there is no examination of the explanted components available.There has been a reported increased incidence of squeaking in ceramic-ceramic hip arthroplasties in which the acetabular component is placed in a more vertical position than nominal.This may be relevant in this case." if additional information and or device become available, this investigation will be reopened.Corrective action/preventive action: per corrective action/preventive action policy and procedures stryker orthopaedics conducted an investigation to evaluate reports of audible noise during motion involving trident ceramic bearing systems.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.Corrective actions were fully implemented as of (b)(6) 2009.

Event Description

It was reported through the attorney for the patient, as a result of a legal claim, that allegedly the patient received a trident acetabular system.It was further alleged that the patient "began experiencing audible sounds during motion emanating from the location of the device." review of the medical records indicated "on (b)(6) 2012 a revision of the right total hip arthroplasty was performed for a diagnosis of failed right bearing surface.The operative report describes general anesthesia and use of the previous anterolateral incision.The operative report describes persistent squeaking, which the patient found intolerable.They removed the femoral head and the acetabular liner, and replaced them with a 40/0° poly insert and a 40/plus-4 metal head.".

• Brand Name: UNKNOWN 36/0 ALUMINA INSERT
• Type of Device: HIP 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7897457
• MDR Text Key: 120989846
• Report Number: 0002249697-2018-02986
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 95