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

Catalog Number UNK_SHC

Device Problem Material Deformation (2976)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient with pain.There is a notch in the neck of the accolade tmzf stem.

Manufacturer Narrative

An event regarding range of motion involving an accolade stem and a trident shell was reported.The event was confirmed following a medical review.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: procedure-related factors: cup malposition with 10° mismatch in anteversion between cup and acetabular bone.Patient-related factors none evident.Device-related factors: none.Diagnosis: cup malposition with 10° mismatch in anteversion between cup and acetabular bone has contributed to an impingement condition in the arthroplasty with a notching effect with visible indentation in the accolade tmzf stem neck.No revision surgery has been reported thus far.Device history review: not performed as lot information was not provided.Complaint history review: not performed as lot information was not provided.Conclusions: a review of the provided medical records by a clinical consultant concluded "cup malposition with 10° mismatch in anteversion between cup and acetabular bone has contributed to an impingement condition in the arthroplasty with a notching effect with visible indentation in the accolade tmzf stem neck.The presence of a stem neck indentation is unequivocal evidence for the presence of an impingement condition somewhere in the arthroplasty with ¿notching¿ between metal cup rim (or mdm) and stem neck.No revision surgery has been reported thus far." no further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient with pain.There is a notch in the neck of the accolade tmzf stem.

• Brand Name: UNKNOWN ACCOLADE TMZF STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7132537
• MDR Text Key: 95317499
• Report Number: 0002249697-2017-03647
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• 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: 02/13/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 02/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other