MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-0435

Device Problems Degraded (1153); Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problems Pain (1994); Injury (2348)

Event Date 05/24/2017

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

Revision of a accolade i hip stem and 36mm +5 lfit head.Resmod stem, 32 ceramic head and x3 liner re-implanted.Patient came to doctor's office with complaint of hip pain.The trunnion was worn off like a pencil and notched.Therefore, the head wouldn't stay on and it wore a hole into the poly.This was the cause for the revision.This was a right hip revision.

Manufacturer Narrative

An event regarding wear involving an accolade stem was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor could the root cause be determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Revision of a accolade i hip stem and 36mm +5 lfit head.Resmod stem, 32 ceramic head and x3 liner re-implanted.Patient came to doctor's office with complaint of hip pain.The trunnion was worn off like a pencil and notched.Therefore, the head wouldn't stay on and it wore a hole into the poly.This was the cause for the revision.This was a right hip revision.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6658568
• MDR Text Key: 78125259
• Report Number: 0002249697-2017-01958
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2013
• Device Catalogue Number: 6021-0435
• Device Lot Number: 26624606
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 06/21/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 01/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR