MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 6120-0-737 ACCOLADE 2; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Insufficient Information (3190)

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

Event Date 06/12/2017

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

Patient presented with a periprosthetic fracture.Restoration modular was used as a replacement.

Manufacturer Narrative

An event regarding periprosthetic fracture involving an unknown accolade stem was reported.The event was 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 x-ray by a clinical consultant indicated."this would leave an external trauma of the patient as the most likely cause of the problem.Even though trauma was not reported, both timing and type of fracture are thus consistent with an external trauma of the patient at a time when bone ingrowth fixation was already completed." "procedure-related factors: none.Patient-related factors: patient trauma.Device-related factors: none.Diagnosis: a traumatic overload condition has contributed to a periprosthetic fracture around the accolade ii stem requiring revision." 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: the exact cause of the event could not be determined nor the root cause confirmed however a review of the medical records by a clinical consultant indicated that "this would leave an external trauma of the patient as the most likely cause of the problem.Even though trauma was not reported, both timing and type of fracture are thus consistent with an external trauma of the patient at a time when bone ingrowth fixation was already completed." further information such as device details, return of device, operative reports, & 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

Patient presented with a periprosthetic fracture.Restoration modular was used as a replacement.

• Brand Name: UNKNOWN 6120-0-737 ACCOLADE 2
• 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: 6698068
• MDR Text Key: 79531471
• Report Number: 0002249697-2017-02140
• 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: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• 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: 08/10/2017
• 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: 67 YR
• Patient Weight: 82