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

Catalog Number UNK_SHC

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

It was reported that surgeon revised patient's right hip due to the femoral head disassociating from the accolade stem due to trunnion wear.

Manufacturer Narrative

An event regarding disassociation involving an accolade stem was reported.The event was confirmed.Method and results: device evaluation and results: the device was not returned.Medical records received and evaluation: a review of the provided information by a clinical consultant could confirm the event but could not determine a root cause.Device history review: review indicated all 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 reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, x-rays, operative reports and patient medical records would be helpful in investigating this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

It was reported that surgeon revised patient's right hip due to the femoral head disassociating from the accolade stem due to trunnion wear.

• Brand Name: UNKNOWN ACCOLADE 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5235406
• MDR Text Key: 31577590
• Report Number: 0002249697-2015-03908
• 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: 10/30/2015

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 Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 11/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2016
• 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: 53 YR
• Patient Weight: 136