MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6720-0535

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer reported that during hip surgery using accolade ii system, after rasping femoral canaland choice no.5 surgeon observed that the coating of the stem is in cappuccino color.According to the surgeon stem no.6 needed to be used as a backup implant in order to finish the surgery due to the fact that the surgeon evaluated the risk of implanting the stem no.5 as very high.According to te surgeon decision to use stem no.6 was taken although the risk of bone breakage existed.

Manufacturer Narrative

An event regarding the appearance of discolored ha coating of a accolade stem was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection of the returned device was carried out.This noted the ha coating section of the stem looked tan in color -medical records received and evaluation: no medical records were received for review with a clinical consultant.No adverse consequences to the patient were noted.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: an nc was issued to investigate the event.Following the investigation it was detected that the potential root cause of this issue was due to a gun change out.The faulty gun was installed on ha 3 on the (b)(6) 2016 and was later removed from ha 3 on (b)(6) 2016.As part of the investigation, cytotoxicity and chemical analysis results for complaint parts were found acceptable.

Event Description

Customer reported that during hip surgery using accolade ii system, after rasping femoral canaland choice no.5 surgeon observed that the coating of the stem is in cappuccino color.According to the surgeon stem no.6 needed to be used as a backup implant in order to finish the surgery due to the fact that the surgeon evaluated the risk of implanting the stem no.5 as very high.According to the surgeon decision to use stem no.6 was taken although the risk of bone breakage existed.

• Brand Name: SIZE 5 ACCOLADE II 132 DEG
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6104742
• MDR Text Key: 60362586
• Report Number: 0002249697-2016-03613
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K143085
• 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: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 6720-0535
• Device Lot Number: 56105204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 11/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2016
• 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): Other