MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 6021-0335

Device Problems Biological Environmental Factor (2887); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Unspecified Infection (1930); Toxicity (2333); Injury (2348); Reaction (2414)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Hip was infected.Surgeon debrided wound and found metallosis and pseudotumor within surrounding tissue.Accolade tmzf stem removed with no issues.No replacement was inserted due to current infection.Lot number unknown as no patient label was available.Patients right hip.This was a primary stem that they removed due to infection and put a cement spacer insitu until the infection clears up, at which point they will implant a revision stem.Surgeon did not have any implant stickers in his notes, he doesn't think there is a way to recover these since it was implanted approximately 13 years ago.There was no surgical delay.

Manufacturer Narrative

An event regarding infection and pseudotumor (altr) involving an accolade stem was reported.The infection issue was confirmed.Altr could not be confirmed.Method and results: device evaluation and results: visual inspection was completed on the returned parts, a small amount of bone ingrowth was noted on the coated area of the stem.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated, procedure-related factors: infection is primarily a procedure-related complication with sometimes additional patient-related risk factors about which there is no info in this specific patient.Component malposition cannot be excluded as potential source of metal debris due to lack of x-ray information.Diagnosis: infection of an accolade tmzf stem occurred 7-years post arthroplasty, likely from a source external to the hip requiring a two-stage infection treatment with device removal and antibiotic spacer implantation as first stage.Second stage with reimplantation to be planned once infection is under control.The metallosis/corrosion issue is not evident from the available documentation while a proper diagnosis of pseudotumor requires support from either mri or tissue histopathology which is not available and given the context of infection has likely an other origin until proven otherwise.Device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: a review of the complaint history database shows that there have been no similar reported events for the subject lot code and sterile lot.Conclusions: a review by clinical consultant concluded: infection of an accolade tmzf stem occurred 7-years post arthroplasty, likely from a source external to the hip requiring a two-stage infection treatment with device removal and antibiotic spacer implantation as first stage.Second stage with reimplantation to be planned once infection is under control.The metallosis/corrosion issue is not evident from the available documentation while a proper diagnosis of pseudotumor requires support from either mri or tissue histopathology which is not available and given the context of infection has likely an other origin until proven otherwise.No further investigation for this event is required at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Hip was infected.Surgeon debrided wound and found metallosis and pseudotumor within surrounding tissue.Accolade tmzf stem removed with no issues.No replacement was inserted due to current infection.Lot number unknown as no patient label was available.Patients right hip.This was a primary stem that they removed due to infection and put a cement spacer insitu until the infection clears up, at which point they will implant a revision stem.Surgeon did not have any implant stickers in his notes, he doesn't think there is a way to recover these since it was implanted approximately 13 years ago.There was no surgical delay.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #3
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6171155
• MDR Text Key: 62269099
• Report Number: 0002249697-2016-03894
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K994366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: 6021-0335
• Device Lot Number: 29640902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2009
• 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: 63 YR