MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6721-0435
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The stem fractured at the neck.
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text : not returned to the manufacturer.
Event or Problem Description
The stem fractured at the neck.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an accolade stem was reported.The event was confirmed through 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 stated the following comment: "this product inquiry concerns a 70-year-old gentleman who underwent a primary total hip arthroplasty in 2010 and then 13 years later sustained a fracture of the femoral component at the trunnion.Heterotopic bone and possibly some metallic debris were noted on the x-ray.I can confirm that patient underwent a primary total hip arthroplasty and that he sustained a fracture of the femoral stem since i was able to review x-rays.I cannot confirm that revision occurred since i have no documentation such as office notes, operation notes or post revision x-rays.The root cause of this event cannot be determined with certainty.The causes of femoral stem fracture 13 years after implantation are multifactorial including surgical technique factors, patient factors including activity level and bmi and implant factors.Before any causality can be assigned to the implant, the explanted prosthesis should be returned to stryker for evaluation and examination by stryker engineers to determine if any deficiency is present." -product history review: a review of the device history records could not be performed as lot code information was unknown.-complaint history review: could not be performed as the lot number is unknown.Conclusions: it was reported that the patient was revised due to fracture of the stem trunnion.A review of the provided medical records by a clinical consultant stated the following comment: "this product inquiry concerns a 70-year-old gentleman who underwent a primary total hip arthroplasty in 2010 and then 13 years later sustained a fracture of the femoral component at the trunnion.Heterotopic bone and possibly some metallic debris were noted on the x-ray.I can confirm that patient underwent a primary total hip arthroplasty and that he sustained a fracture of the femoral stem since i was able to review x-rays.I cannot confirm that revision occurred since i have no documentation such as office notes, operation notes or post revision x-rays.The root cause of this event cannot be determined with certainty.The causes of femoral stem fracture 13 years after implantation are multifactorial including surgical technique factors, patient factors including activity level and bmi and implant factors.Before any causality can be assigned to the implant, the explanted prosthesis should be returned to stryker for evaluation and examination by stryker engineers to determine if any deficiency is present." 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.

• Brand Name: SIZE 4 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: 16830187
• Report Number: 0002249697-2023-00439
• Device Sequence Number: 1842451
• Product Code: LPH
• UDI-Device Identifier: 04546540669490
• UDI-Public: 04546540669490
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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: 6721-0435
• Device Catalogue Number: 6721-0435
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 08/23/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Race: Asian