MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6721-0535
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/13/2024
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 conformed via medical review.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: "i can confirm that the patient had a primary right total hip arthroplasty on (b)(6) 2024, with subsequent periprosthetic fracture of the proximal femur since i was able to see an x-ray with the implant and the fracture in place.I was also able to see the implant usage sheet.I can also confirm that the patient underwent a revision on (b)(6) 2024 since i was able to see the implant usage sheet.However, i do not have the operation report or post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of periprosthetic proximal femoral fractures three days or less following primary total hip arthroplasty, in the absence of trauma, which is not reported here, are usually iatrogenic intraoperative causes.This could be from an unrecognized breach in the cortex during broaching or component insertion, or the choice of an implant which was too large for the bone envelope of this patient.While bone quality could be an issue, this patient did not demonstrate significant osteopenia." -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 fracture.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a primary right total hip arthroplasty on (b)(6) 2024 with subsequent periprosthetic fracture of the proximal femur since i was able to see an x-ray with the implant and the fracture in place.I was also able to see the implant usage sheet.I can also confirm that the patient underwent a revision on (b)(6) 2024 since i was able to see the implant usage sheet.However, i do not have the operation report or post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of periprosthetic proximal femoral fractures three days or less following primary total hip arthroplasty, in the absence of trauma, which is not reported here, are usually iatrogenic intraoperative causes.This could be from an unrecognized breach in the cortex during broaching or component insertion, or the choice of an implant which was too large for the bone envelope of this patient.While bone quality could be an issue, this patient did not demonstrate significant osteopenia." 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
Right hip.Patient revised due to periprosthetic fracture.No other information available due to hospital policy.

• Brand Name: SIZE 5 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20391164
• Report Number: 0002249697-2024-01373
• Device Sequence Number: 8008971
• Product Code: LPH
• UDI-Device Identifier: 04546540669506
• UDI-Public: 04546540669506
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2024

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 Catalogue Number: 6721-0535
• Device Lot Number: 19838158A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2024
• 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; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female