MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 8 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6720-0837
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Device not returned.
Event or Problem Description
Patient reported fractured left femur shortly after surgery.Update (b)(6) 2022 wg: per stryker rep, patient was revised to a restoration modular stem construct with dall miles cables.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving an accolade stem was reported.The event was confirmed through 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 information by a clinical consultant indicated: "this patient sustained a periprosthetic fracture done through a direct anterior approach and was re-operated two days later for open reduction and internal fixation with the use of a restoration modular implant.As mentioned above the direct anterior approach is associated with increased complications in obese patients including periprosthetic fractures.It is quite possible that the implant chosen was too big for the patient or that the reaming and preparation process may have been compromised because of the patient's obesity and the use of the direct anterior approach.If the femoral cortex was violated during the preparation process periprosthetic fracture can occur.Unless the area of the tip of the implant is visualized directly, this may not be detected.The root cause of this event in my opinion is iatrogenic in that either the implant was too large for the patient or in the preparation process violation of the cortex and nondisplaced fracture may have occurred which subsequently displaced." 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 of the femur two days after the primary implantation.A review of the provided medical information by a clinical consultant indicated: "this patient sustained a periprosthetic fracture done through a direct anterior approach and was re-operated two days later for open reduction and internal fixation with the use of a restoration modular implant.As mentioned above the direct anterior approach is associated with increased complications in obese patients including periprosthetic fractures.It is quite possible that the implant chosen was too big for the patient or that the reaming and preparation process may have been compromised because of the patient's obesity and the use of the direct anterior approach.If the femoral cortex was violated during the preparation process periprosthetic fracture can occur.Unless the area of the tip of the implant is visualized directly, this may not be detected.The root cause of this event in my opinion is iatrogenic in that either the implant was too large for the patient or in the preparation process violation of the cortex and nondisplaced fracture may have occurred which subsequently displaced." 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
Patient reported fractured left femur shortly after surgery.Update 05/may/2022 wg: per stryker rep, patient was revised to a restoration modular stem construct with dall miles cables.

• Brand Name: SIZE 8 ACCOLADE II 132 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 14338488
• Report Number: 0002249697-2022-00658
• Device Sequence Number: 14780581
• Product Code: LPH
• UDI-Device Identifier: 04546540664518
• UDI-Public: 04546540664518
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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 Expiration Date: 07/08/2026
• Device Model Number: 6720-0837
• Device Catalogue Number: 6720-0837
• Device Lot Number: 86581504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 91 KG