MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6720-0435
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.Device not returned to the manufacturer.
Event or Problem Description
It was reported by stryker sales rep that primary operation was done on (b)(6) 2022.Patient was discharged and come back for physio.Patient complained of pain after and found femur mid-shaft fracture.The revision surgery is scheduled.
Event or Problem Description
It was reported by stryker sales rep that primary operation was done on (b)(6) 2022.Patient was discharged and come back for physio.Patient complained of pain after and found femur mid-shaft fracture.The revision surgery is scheduled.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving an accolade stem was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: this patient sustained a periprosthetic fracture of the femur which occurred in the immediate postoperative period.Revision surgery was scheduled approximately 12 days after the index procedure.Periprosthetic fracture is a common complication following cementless femoral components.The causes of periprosthetic fracture or multifactorial but almost always are iatrogenic due to surgical technique.This patient had what appears to be a very thin lateral cortex.Fracture can occur when broaching the proximal femur for the implant.An unrecognized fissure/fracture can occur when broaching the proximal femur for the implant.The fracture can displace upon weight bearing in the early postoperative period.Periprosthetic fracture can also occur when an implant that is relatively too large for the femoral canal is driven into the canal.This is especially seen in patients with thin or osteopenic bone.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 has been no other similar events for the lot referenced.Conclusions: an event regarding periprosthetic fracture was reported.The event was confirmed through clinician review who indicated:this patient sustained a periprosthetic fracture of the femur which occurred in the immediate postoperative period.Revision surgery was scheduled approximately 12 days after the index procedure.Periprosthetic fracture is a common complication following cementless femoral components.The causes of periprosthetic fracture or multifactorial but almost always are iatrogenic due to surgical technique.This patient had what appears to be a very thin lateral cortex.Fracture can occur when broaching the proximal femur for the implant.An unrecognized fissure/fracture can occur when broaching the proximal femur for the implant.The fracture can displace upon weight bearing in the early postoperative period.Periprosthetic fracture can also occur when an implant that is relatively too large for the femoral canal is driven into the canal.This is especially seen in patients with thin or osteopenic bone.The exact cause of the event cannot be confirmed as insufficient information.Further information such as additional x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.

• Brand Name: SIZE 4 ACCOLADE II 132 DEG
• Common Device Name: 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14460630
• Report Number: 0002249697-2022-00725
• Device Sequence Number: 14581627
• Product Code: LPH
• UDI-Device Identifier: 04546540664471
• UDI-Public: 04546540664471
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K103479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: 6720-0435
• Device Catalogue Number: 6720-0435
• Device Lot Number: 87803103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female