MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE HFX SIZE NO 5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6077-0537
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "rev rtha - periprosthetic fracture.Accolade hfx and 36mm +10 head coming out and competitor going back in.Original cup is also competitor." spoke with rep.Rep confirmed femoral fracture, and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving an accolade stem was reported.The event was not confirmed.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: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device was not returned.Complaint history review: could not be performed as the device was not returned.Conclusions: it was reported that the patient was revised due to periprosthetic fracture.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.H3 other text : not available.

• Brand Name: ACCOLADE HFX SIZE NO 5
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19215320
• Report Number: 0002249697-2024-00667
• Device Sequence Number: 15503422
• Product Code: LPH
• UDI-Device Identifier: 07613327021219
• UDI-Public: 07613327021219
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2024

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: 6077-0537
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Male
• Patient Weight: 22 KG