MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 8 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6720-0837

Device Problems Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported on the implant, looks like frizzy white cotton like material.It was reported they decided not to implant and allegedly kept implant and original box.

Manufacturer Narrative

An event regarding foreign material involving a accolade stem was reported.The event was confirmed.Method and results: -device evaluation and results: a visual inspection of the returned device was carried out.This noted a fibre like material on the ha coating of the device.The device was otherwise unremarkable.-medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other events for the reported lot.Conclusions: (b)(4) has been raised to investigate the event.(b)(4) was raised on 23-feb-2017 and closed on 31-mar-2017.The scope and corrective actions are detailed within the nc and corresponding (b)(4).(b)(4) determined the fiber was most likely introduced to the accolade ii stem in the ha coating and packaging business units.

Event Description

It was reported on the implant, looks like frizzy white cotton like material.It was reported they decided not to implant and allegedly kept implant and original box.

• Brand Name: SIZE 8 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: suzanne neuschwanter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6307144
• MDR Text Key: 67110049
• Report Number: 0002249697-2017-00475
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540664518
• UDI-Public: (01)04546540664518(11)160222(17)210228(10)54727401
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K143085
• 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: 04/13/2017

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: 02/28/2021
• Device Catalogue Number: 6720-0837
• Device Lot Number: 54727401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other