MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 1 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6721-0127

Device Problems Unintended Movement (3026); Migration (4003)

Patient Problems Bone Fracture(s) (1870); Unequal Limb Length (4534); Insufficient Information (4580)

Event Date 07/06/2022

Event Type  Injury  

Event Description

5 week follow up shows accolade2 stem subsidence.Patient presented with mal aligned and short leg.Ct shows femoral fracture.Surgeon reports no intraop fracture noted.Patient denies fall.

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Manufacturer Narrative

Reported event: an event regarding subsidence involving a accolade stem was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: the devices were not returned however photographs were provided for review.A review of the provided photographs indicated the devices were covered in blood and tissue.Minor scratches and damage consistent with attempted explantation.Nothing else remarkable noted.Material analysis, functional, and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of medical records with a clinical consultant indicated: this patient underwent a primary cementless right total hip arthroplasty and at five week follow-up visit she was noted to have rather severe subsidence.A ct scan revealed a fracture.Revision surgery was carried out according to the summary.I can confirm that subsidence of the implant occurred since i was able to compare the immediate postop x-ray with the five-week x-ray.I cannot confirm a fracture since i cannot see it on the x-ray and i have no ct scan to examine.I cannot confirm that revision was carried out since i have no documentation such as office notes, an operative note, and post revision x-rays.The cause of subsidence of an implant in a patient who has denied trauma or a fall, an who is found to have a fracture, in my opinion is almost always iatrogenic.Most likely there was an unrecognized fracture which displaced and allowed more space in the femur causing subsidence.Having said that i would have concern after seeing the immediate postop x-ray because there was no contact between the medial portion of the implant and the lateral portion of the calcar so movement of the implant in a distal direction and into a varus attitude could be possible upon weight-bearing.Subsidence in the absence of fracture is almost always due to an implant that is somewhat undersized for the patient.I would not assign any cause to the implant itself." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the devices were not returned however photographs were provided for review.A review of the provided photographs indicated the devices were covered in blood and tissue.Minor scratches and damage consistent with attempted explantation.Nothing else remarkable noted.A review of medical records with a clinical consultant indicated: this patient underwent a primary cementless right total hip arthroplasty and at five week follow-up visit she was noted to have rather severe subsidence.A ct scan revealed a fracture.Revision surgery was carried out according to the summary.I can confirm that subsidence of the implant occurred since i was able to compare the immediate postop x-ray with the five-week x-ray.I cannot confirm a fracture since i cannot see it on the x-ray and i have no ct scan to examine.I cannot confirm that revision was carried out since i have no documentation such as office notes, an operative note, and post revision x-rays.The cause of subsidence of an implant in a patient who has denied trauma or a fall, an who is found to have a fracture, in my opinion is almost always iatrogenic.Most likely there was an unrecognized fracture which displaced and allowed more space in the femur causing subsidence.Having said that i would have concern after seeing the immediate postop x-ray because there was no contact between the medial portion of the implant and the lateral portion of the calcar so movement of the implant in a distal direction and into a varus attitude could be possible upon weight-bearing.Subsidence in the absence of fracture is almost always due to an implant that is somewhat undersized for the patient.I would not assign any cause to the implant itself." 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

5 week follow up shows accolade2 stem subsidence.Patient presented with mal aligned and short leg.Ct shows femoral fracture.Surgeon reports no intraop fracture noted.Patient denies fall.

• Brand Name: SIZE 1 ACCOLADE II 127 DEG
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15109702
• MDR Text Key: 296660430
• Report Number: 0002249697-2022-01084
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540669469
• UDI-Public: 04546540669469
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

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 Model Number: 6721-0127
• Device Catalogue Number: 6721-0127
• Device Lot Number: 74391603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 09/30/2022
• Supplement Dates FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2019
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 53 KG