MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 2 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6721-0230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
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 information by a clinical consultant indicated: "this patient sustained a periprosthetic fracture approximately one month following implantation of a cementless total hip arthroplasty.No information is given as to whether or not trauma contributed to the fracture.I can confirm that the primary procedure occurred since i was able to review the x-rays.I can confirm the fracture as well.I can confirm that a revision was carried out since i was able to see the original stryker stickers for the revision components but i do not have an operation report or any other documentation such as doctor¿s notes or hospital records.The causes of periprosthetic fracture approximately one month following primary implantation are multifactorial including surgical technique factors and patient factors including trauma.If no trauma occurred then it is possible that during the procedure the femoral cortex was breached creating a stress riser resulting in femoral fracture." 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: it was reported that the patient was revised due to periprosthetic femoral fracture.The event was confirmed by clinician review of the provided x-ray images: "this patient sustained a periprosthetic fracture approximately one month following implantation of a cementless total hip arthroplasty.No information is given as to whether or not trauma contributed to the fracture.I can confirm that the primary procedure occurred since i was able to review the x-rays.I can confirm the fracture as well.[.] the causes of periprosthetic fracture approximately one month following primary implantation are multifactorial including surgical technique factors and patient factors including trauma.If no trauma occurred then it is possible that during the procedure the femoral cortex was breached creating a stress riser resulting in femoral fracture." 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 or Problem Description
It was reported the patient's right hip was revised due to a femoral periprosthetic fracture.A stem and head were revised to a restoration modular stem construct, ceramic head and 4 cable and sleeve sets.Rep confirmed there are no allegations against the revised femoral head.

• Brand Name: SIZE 2 ACCOLADE II 127 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: 17187028
• Report Number: 0002249697-2023-00710
• Device Sequence Number: 15155669
• Product Code: LPH
• UDI-Device Identifier: 04546540669476
• UDI-Public: 04546540669476
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2023

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 Model Number: 6721-0230
• Device Catalogue Number: 6721-0230
• Device Lot Number: 98199802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American