MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE STEM; HIP IMPLANT

Catalog Number UNK_SHC

Device Problems Break (1069); Fracture (1260); Material Deformation (2976)

Patient Problems Injury (2348); Osteolysis (2377)

Event Date 01/04/2018

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

It was reported that the accolade stem fractured through the trunnion.Implant was originally implanted approximately 11 years ago.

Manufacturer Narrative

An event regarding a crack/fracture involving an unknown accolade stem was reported.A review by a clinical consultant confirmed, accolade stem crack/fracture, stem / head disassociation and osteolysis.Method & results: device evaluation and results: not performed as the device was not returned for evaluation.Medical records received and evaluation: a review of the provided x-ray by a clinical consultant indicated: i have seen the info for this patient, actually only one ap x-ray, for this patient with a catastrophic trunnion failure of an accolade tmzf stem with trident cup and poly bearing some 11-years post implantation.The event is confirmed on the ap x-ray with catastrophic trunnion failure with major substance loss of the trunnion and disassociation of the femoral head from the trunnion, the femoral head retained in the cup liner with metallic debris in and around the joint space.There is osteolysis both around the cup and the proximal femur to indicate, a problem has been around in the arthroplasty for quite some time, the cause is however not readily apparent.There are frequently issues with component position but this patient appears to have a rather adequate component position, both stem and cup for inclination, anteversion and centre of rotation.This is within the restraints of only an ap view.Cup anteversion can be rather variable between patients and a good match of the cup with the acetabular bone plane can only be exactly measured on a lateral x-ray, not available for this patient.As such can component malposition still not be excluded completely.On the ap view it appears however ¿within range of average¿ while no other potential contributing issues in the arthroplasty are seen that might play a role in the current failure mode such as for instance heterotopic ossifications that are not present in this hip.As such can no clear failure cause be established due to lack of adequate information.More imaging and/or clinical and/or retrieval information would be required to help solve this case device history review could not be performed as the device lot is unknown.Complaint history review could not be performed as the device lot is unknown.Conclusions: a review by a clinical consultant concluded: as such can no clear failure cause be established due to lack of adequate information.More imaging and/or clinical and/or retrieval information would be required to help solve this case.Further information such as device details, return of device, operative reports, additional x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

It was reported that the accolade stem fractured through the trunnion.Implant was originally implanted approximately 11 years ago.Update 23 february 2018: a review by a clinical consultant has confirmed: catastrophic trunnion failure of an accolade tmzf stem.Disassociation of the femoral head from the trunnion.Osteolysis around both the accolade stem and trident shell.Unknown trident shell and unknown femoral head added to product grid.

• Brand Name: UNKNOWN ACCOLADE STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7231649
• MDR Text Key: 98695208
• Report Number: 0002249697-2018-00281
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR