MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 32/PLUS-4 ALUMINA HEAD; HIP IMPLANT

Catalog Number UNK_JR

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Discomfort (2330); Injury (2348)

Event Date 12/15/2011

Event Type  Injury  

Manufacturer Narrative

An event regarding squeaking, fragmentation and wear 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 by a clinical consultant revealed: on (b)(6) 2005 she underwent a primary right total hip arthroplasty for a diagnosis of osteoarthritis of the right hip." [.] "an office visit of (b)(6) 2005 notes the patient to be "doing well".On (b)(6) 2005 it was noted, "walks with a cane.Needs increased range of motion and strengthening.Doing well.Very pleased.'' when seen on (b)(6) 2007 she complained of right lateral thigh discomfort for several weeks described as a "burning sensation times three to four weeks"." [.] "on (b)(6) 2010 she was seen complaining of right hip pain "since sunday climbing stairs.It now creaks".On physical examination she had a full range of motion with creaking appreciated and five over five strength.She was on medication for asthma.When seen on (b)(6) 2010 it was noted, "increased pain and squeaking right hip.May need revision." an arthrogram of the right hip performed on (b)(6) 2010 showed "multiple loose bodies (6mm) in pseudocapsule, likely synovial osteochondromatosis.No evidence of fracture or hardware failure." on (b)(6) 2010 a revision of the right total hip arthroplasty was performed for a diagnosis of failed right tha.The operative report describes general anesthesia and the use of the previous posterolateral approach.The operative report further states that the patient complained of squeaking and increased discomfort, and that a recent breast reduction surgery delayed her treatment.500cc's of black synovial fluid was noted, as well as a posterior notch on the neck of the prosthesis.The liner was removed and the cup was anteverted approximately 40° and "the ceramic ball exhibited lots of metal debris".The report states, "debris.Below fascia posteriorly, mass the patient complained of'.Erosion of the inner ceramic liner was noted." [.] "at an office visit of (b)(6) 2010 the patient was using a walker and x-ray showed "good alignment".It was noted, "she had complete disintegration of the ceramic liner with morsalization of the ceramic." [.] "a (b)(6) 2010 ap of the pelvis and lateral of the right hip demonstrate radiodense fragments around the joint with the head deeper and excentric in the acetabulum consistent with an alumina liner fracture.An (b)(6) 2010 spot view of the right hip is unchanged from the previous description.An (b)(6) 2010 ap of the pelvis and ap and lateral of the right hip demonstrate a revision right total hip arthroplasty with three screws in the acetabulum." [.] "in this obese patient with an excessively anteverted acetabular component, posterior neck impingement resulted in recurrent subluxations and, likely, fracture of the ceramic liner during a reduction maneuver.Delay in revision surgery from the apparent liner fracture noted on the (b)(6) 2010 x-ray until revision surgery on (b)(6) 2010 resulted in further fragmentation, metallosis, and soft tissue reaction.Examination of the explanted components might determine if factors of faulty prosthetic manufacturing or materials were involved in this clinical situation, which appears to be primarily related to acetabular component malposition and resulting impingement." product history review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the investigation confirmed the squeaking and wear of the implant and determined the malposition of the shell to be the root cause.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 is documented in capa (b)(4).In capa (b)(4), 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.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 allegedly, "the patient received a trident ceramic on ceramic hip system." it was further alleged that, "the patient is experiencing 'significant squeaking and discomfort in the area of her hip.'" update as per medical review: "in this obese patient with an excessively anteverted acetabular component, posterior neck impingement resulted in recurrent subluxations and, likely, fracture of the ceramic liner during a reduction maneuver.Delay in revision surgery from the apparent liner fracture noted on the (b)(6) 2010 x-ray until revision surgery on (b)(6) 2010 resulted in further fragmentation, metallosis, and soft tissue reaction.Examination of the explanted components might determine if factors of faulty prosthetic manufacturing or materials were involved in this clinical situation, which appears to be primarily related to acetabular component malposition and resulting impingement.".

• Brand Name: UNKNOWN 32/PLUS-4 ALUMINA HEAD
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8267468
• MDR Text Key: 133752171
• Report Number: 0002249697-2019-00252
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 01/22/2019
• 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: 54 YR
• Patient Weight: 103