MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA C-TAPER HEAD 32MM/-2.5; HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

Catalog Number 17-32-3E

Device Problem Noise, Audible (3273)

Patient Problems Irritation (1941); Pain (1994); Discomfort (2330); Injury (2348)

Event Date 01/26/2010

Event Type  Injury  

Manufacturer Narrative

An event regarding audible noise involving a ceramic head was reported.The event 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) 2006 she underwent a primary right total hip arthroplasty for a diagnosis of osteoarthritis of the right hip.The operative report describes spinal anesthesia and an anterolateral approach.She was seen on (b)(6) 2007 at which time it was noted, "very satisfied with right total hip, complains of left hip".On (b)(6) 2008 she was seen in the office at which time it was noted, "complains of cracking and knocking noise.Believes from her right knee, not associated with any pain" the note further states the doctor believes it was coming from the hip as a "variant of squeak.Potential complication of ceramic - ceramic joints''.At an office visit of (b)(6) 2009 it is noted, "squeaking persisted and more prevalent.Recently complains of anterior right thigh achiness with active flexion." on physical examination it was noted "squeak readily heard".X-ray demonstrated no change on the right and an increased osteoarthritic left hip.X-ray revealed "no wear or loosening right, severe osteoarthritis left".The patient was to consider revision.On (b)(6) 2011 a revision of the right total hip was performed with the patient complaining of pain and squeaking in the right total hip.The components were changed to biomet modular revision components and a trochanteric bolt and cerclage wires were utilized to reattach the trochanteric fragment.X-ray printouts related to the right hip available for review include a series dated (b)(6) 2011, which is an ap of the pelvis, lateral of the right hip and lateral of the left hip, demonstrating an uncemented right total hip arthroplasty with two screws in the acetabulum.An alumina head is noted on the femur.The cup is at approximately 60°, which is more vertical than nominal, and the alumina head is reduced.There is no evidence of wear or loosening of the femoral or acetabular components.X-rays dated (b)(6) 2011 are multiple views of the right hip, which are unchanged.On (b)(6) 2011 an ap of the right hip demonstrates skin staples and a revision modular long-stem with a trochanteric bolt and wires.The acetabulum is in nominal position.Two screws are noted in the acetabulum and a larger head is noted, which is reduced and more radiodense than the previous alumina head.X-rays dated (b)(6) 2011, (b)(6) 2012 and (b)(6) 2013 are multiple views of the right hip with a trochanteric nonunion and displacement, and various stages of wire breakage.X-rays dated (b)(6) 2013 and (b)(6) 2014 are multiple views of the right hip on which the bolt and most of the wire fragments are removed.The trochanteric fragment is still displaced and the hip components are unchanged.There is no examination of the explanted stryker components available.Increased noise phenomena with ceramic-ceramic total hip arthroplasty has been reported with vertical placement of the acetabular component.This is likely relevant in this case.The anterolateral thigh pain probably represents lumbar radiculitis as initially described in 2004 before the primary hip surgery.Rather than remove the well-fixed femoral and acetabular components at the (b)(6) 2011 extensive revision surgery, replacing the alumina head and liner to a metal-poly bearing would have addressed the squeaking problem without exposing the patient to the subsequent complications of the long-stem revision and trochanteric osteotomy.There is no evidence the patient's current complaints relate to design, manufacturing or material defects in her primary stryker implants inserted on (b)(6) 2006." product history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: no other events were reported for the lot referenced.Conclusions: the reported event was confirmed by medical review.A review of the medical records revealed that " the cup is at approximately 60°, which is more vertical than nominal, and the alumina head is reduced.There is no evidence of wear or loosening of the femoral or acetabular components.There is no examination of the explanted stryker components available.Increased noise phenomena with ceramic-ceramic total hip arthroplasty has been reported with vertical placement of the acetabular component.This is likely relevant in this case.The anterolateral thigh pain probably represents lumbar radiculitis as initially described in 2004 before the primary hip surgery.Rather than remove the well-fixed femoral and acetabular components at the (b)(6) 2011 extensive revision surgery, replacing the alumina head and liner to a metal-poly bearing would have addressed the squeaking problem without exposing the patient to the subsequent complications of the long-stem revision and trochanteric osteotomy.There is no evidence the patient's current complaints relate to design, manufacturing or material defects in her primary stryker implants inserted on (b)(6) 2006." 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.

Event Description

It was reported that, "it was reported as a result of a filed lawsuit; on or about (b)(6) 2006, the patient underwent a total right hip arthroplasty surgery at (b)(6) hospital in (b)(6) involving the implantation of the trident device.It was further reported that, in (b)(6) of 2007, the patient began experiencing extreme pain and began hearing audible noises including squeaking which emanated from the location of her right hip.It was further alleged that, as a result of the pain and squeaking which developed, the patient has experienced and continues to experience constant irritation and discomfort in the location of her right hip." update as per medical records noted "on (b)(6) 2011 a revision of the right total hip was performed with the patient complaining of pain and squeaking in the right total hip.".

• Brand Name: ALUMINA C-TAPER HEAD 32MM/-2.5
• Type of Device: HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
• 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 Key: 7862134
• MDR Text Key: 119781059
• Report Number: 0002249697-2018-02820
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04546540195616
• UDI-Public: 04546540195616
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K003391
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2010
• Device Catalogue Number: 17-32-3E
• Device Lot Number: 15774801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2005
• 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: 46 YR
• Patient Weight: 88