MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 6 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6721-0635
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported: "revision was performed due to periprosthetic fracture." spoke to rep.During primary procedure, surgeon broached for a size 4 accolade stem.After trialing the head and upon (intentional) dislocation, the stem was observed to be loose.Patient was inspected for bone fracture, none was seen.Surgeon then broached to a 5, which countersunk during trialing of the stem.Surgeon broached to a 6, which had no issues, and a size 6 stem was implanted.An x-ray taken post-op while the patient was in the recovery room showed a femoral fracture.Patient was revised to a restoration modular stem construct with a new femoral head.Rep confirmed there were no allegations against the revised femoral head, and confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
As reported: "revision was performed due to periprosthetic fracture." spoke to rep.During primary procedure, surgeon broached for a size 4 accolade stem.After trialing the head and upon (intentional) dislocation, the stem was observed to be loose.Patient was inspected for bone fracture, none was seen.Surgeon then broached to a 5, which countersunk during trialing of the stem.Surgeon broached to a 6, which had no issues, and a size 6 stem was implanted.An x-ray taken post-op while the patient was in the recovery room showed a femoral fracture.Patient was revised to a restoration modular stem construct with a new femoral head.Rep confirmed there were no allegations against the revised femoral head, 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 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 records by a clinical consultant indicated: this is a case of an unrecognized periprosthetic femoral fracture at the time of broaching or implantation of a cementless accolade ii implant.In the recovery room, a postoperative x-ray revealed the periprosthetic fracture.I can confirm that the patient underwent the total hip arthroplasty and that a periprosthetic fracture occurred assuming that the unmarked x-ray my examined people was the immediate postoperative x-ray.The root cause of this event cannot be determined with certainty.Having said that, unless there was some inherent defect in the femur, the cause of a periprosthetic fracture found on recovery room x-ray is virtually always iatrogenic with an attempt to implant a prosthesis which is too large for the patient's bone envelope.Misdirection of reamers or broaches can also encroach on the cortex leading to weakness or a fissure resulting in fracture upon insertion of the implant.From the one x-ray that i saw, femoral component appears to be oversized.In my opinion, the fact the size 4 went in easily and was loose, and the size 5 was countersunk, and the 6 went in with no issues leads me to believe the femur was already fractured at that time.I would not assign any causality to the implant itself.-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: a review of the provided medical records by a clinical consultant indicated: this is a case of an unrecognized periprosthetic femoral fracture at the time of broaching or implantation of a cementless accolade ii implant.In the recovery room, a postoperative x-ray revealed the periprosthetic fracture.I can confirm that the patient underwent the total hip arthroplasty and that a periprosthetic fracture occurred assuming that the unmarked x-ray my examined people was the immediate postoperative x-ray.The root cause of this event cannot be determined with certainty.Having said that, unless there was some inherent defect in the femur, the cause of a periprosthetic fracture found on recovery room x-ray is virtually always iatrogenic with an attempt to implant a prosthesis which is too large for the patient's bone envelope.Misdirection of reamers or broaches can also encroach on the cortex leading to weakness or a fissure resulting in fracture upon insertion of the implant.From the one x-ray that i saw, femoral component appears to be oversized.In my opinion, the fact the size 4 went in easily and was loose, and the size 5 was countersunk, and the 6 went in with no issues leads me to believe the femur was already fractured at that time.I would not assign any causality to the implant itself.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SIZE 6 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15576919
• Report Number: 0002249697-2022-01462
• Device Sequence Number: 12453354
• Product Code: LPH
• UDI-Device Identifier: 04546540669513
• UDI-Public: 04546540669513
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K120578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 6721-0635
• Device Catalogue Number: 6721-0635
• Device Lot Number: 95639107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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: 73 YR
• Patient Sex: Female