MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6720-0535

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

Procedure: the patient underwent left total hip arthroplasty (b)(6) 2020.X-rays demonstrated an unstable periprosthetic femoral fracture (b2).Patient underwent revision of left hip, all components exchanged except cup (and screws) (b)(6) 2020.

Event Description

Procedure: the patient underwent left total hip arthroplasty (b)(6) 2020.X-rays demonstrated an unstable periprosthetic femoral fracture (b2).Patient underwent revision of left hip, all components exchanged except cup (and screws) (b)(6) 2020.

Manufacturer Narrative

Reported event: an event regarding periprosthetic fracture involving a accolade stem was reported.The event was confirmed via clinical 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 stated that : post operative x-rays show a pressfit tha in expected position.The components are in expected position and are appropriately sized.Subsequent x-rays show a long spiral periprosthetic fracture of the proximal femur.The component has subsided and has lost fixation necessitating revision.Post revision x-rays show a long restoration modular stem and cerclage cables securing the fracture.Initial post op films do not show a fracture line.The most common reason for this to happen is a small calcar fracture intraoperatively that was not recognized intra-operatively that goes on to propagate.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.A review of the provided medical records by a clinical stated that : post operative x-rays show a pressfit tha in expected position.The components are in expected position and are appropriately sized.Subsequent x-rays show a long spiral periprosthetic fracture of the proximal femur.The component has subsided and has lost fixation necessitating revision.Post revision x-rays show a long restoration modular stem and cerclage cables securing the fracture.Initial post op films do not show a fracture line.The most common reason for this to happen is a small calcar fracture intraoperatively that was not recognized intra-operatively that goes on to propagate.Further information such as return of the device, pathology reports, operative reports 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 5 ACCOLADE II 132 DEG
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10459556
• MDR Text Key: 204542650
• Report Number: 0002249697-2020-01752
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540664488
• UDI-Public: 04546540664488
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 6720-0535
• Device Catalogue Number: 6720-0535
• Device Lot Number: 67586003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 95