MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE II STEM; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Insufficient Information (3190)

Patient Problems Arthritis (1723); Bone Fracture(s) (1870); Injury (2348)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Sales rep reported reason for revision: femoral fracture right hip.

Manufacturer Narrative

An event regarding a periprosthetic fracture involving an unknown accolade stem was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.-medical records received and evaluation: a review of the provided medical records indicated: "there is no evidence available in the current case to suggest that device-related issues have played a role while the discussed adverse mix of patient- and procedure-related factors should be considered more than adequate to have caused the periprosthetic fracture problem in this patient.This case is not device-related.Diagnosis: - an adverse mix of patient-related (osteoporosis) and procedure-related factors (surgical preparation in osteoporotic bone) have caused a peri-prosthetic fracture requiring revision surgery." -device history review could not be performed as the device lot is unknown.-complaint history review could not be performed as the device lot is unknown.Conclusions: a medical review was completed and diagnosed that "an adverse mix of patient-related (osteoporosis) and procedure-related factors (surgical preparation in osteoporotic bone) have caused a peri-prosthetic fracture requiring revision surgery" further information however such as device details, return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

Sales rep reported reason for revision: femoral fracture right hip.

• Brand Name: UNKNOWN ACCOLADE II STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6443204
• MDR Text Key: 71160321
• Report Number: 0002249697-2017-01050
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 115