MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-0537

Device Problems Collapse (1099); Device Operates Differently Than Expected (2913); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problems Pain (1994); Injury (2348); Limited Mobility Of The Implanted Joint (2671)

Event Date 09/22/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received, will be provided in the supplemental report.

Event Description

Patient had a primary surgery on left hip (b)(6) 2007.Patient is now experiencing loss of mobility, instability, short leg and back pain.Surgeon took x-rays which showed the ball collapsed on top of stem.The 44 v-40 metal head had worn down the trunnion on the acolade #5.The stem was removed and a mod/ cone/ conical replaced the accolade stem.The 44 v-40 metal head had worn down the trunnion on the acolade #5.

Manufacturer Narrative

An event regarding alleged instability, pain, short leg and wear involving an accolade stem was reported.The event was confirmed for wear.Device evaluation and results: could not be performed as no items associated with the event were returned for evaluation.Medical records received and evaluation: a review of the primary operative report, office notes, mri report, revision operative report, and x-ray printouts by the consulting clinician indicated "on october 6, 2016 revision left total hip arthroplasty femur and acetabular liner was performed for a post-operative diagnosis of "complication of internal orthopaedic prosthetic device"."the report notes, "moderate amount of dark gray synovial fluid sent to the lab.Metallosis and synovitis.Femoral head grossly loose on misshapen trunnion"."there is no examination of the explanted components, no dated serial x-rays or mri images, no documented clinical follow-up between september 13, 2007 and march 11, 2016 available for review.Based upon the information available for review, no determination can be made regarding the cause of this clinical situation regarding the head/trunnion junction in this case." 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 events for the reported lot.Conclusions: the event was confirmed.However, the root cause could not be determined based on review of the primary operative report, office notes, mri report, revision operative report, and x-ray printouts by the consulting clinician indicated "there is no examination of the explanted components, no dated serial x-rays or mri images, no documented clinical follow-up between september 13, 2007 and march 11, 2016 available for review.Based upon the information available for review, no determination can be made regarding the cause of this clinical situation regarding the head/trunnion junction in this case." additionally, the reported device is not associated with a recall.If further information and/or devices becomes available, this investigation will be re-opened.

Event Description

Patient had a primary surgery on left hip (b)(6) 2007.Patient is now experiencing loss of mobility, instability, short leg and back pain.Surgeon took x-rays which showed the ball collapsed on top of stem.The 44 v-40 metal head had worn down the trunnion on the acolade #5.The stem was removed and a mod/ cone/ conical replaced the accolade stem.The 44 v-40 metal head had worn down the trunnion on the acolade #5.Update: per sales rep, the 44 v-40 metal head had worn down the trunnion on the acolade #5.The stem was removed and a mod/ cone/ conical replaced the accolade stem.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6148939
• MDR Text Key: 61548949
• Report Number: 0002249697-2016-03830
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• 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: 12/26/2017

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 Expiration Date: 01/31/2012
• Device Catalogue Number: 6021-0537
• Device Lot Number: 20110601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: 11/27/2017
• Supplement Dates FDA Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2007
• 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: 59 YR
• Patient Weight: 113