MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-0130

Device Problems Disconnection (1171); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Pain (1994); Injury (2348)

Event Date 01/25/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

The customer, reported that he revised an accolade stem (6021-0130, lot 17348701) that had disengaged with the head (6260-9-236, lot 6apmpa) the original surgery was done 10 years ago and original post op x-rays looked fine.Patient presented with pain and stated that the affected side never 'felt right' compared to the other side.

Manufacturer Narrative

Additional information: product available to stryker; returned to manufacturer on; device evaluated by mfg.An event regarding disassociation involving an acccolade tmzf stem was reported.The event was confirmed.Method & results: device evaluation and results: a material analysis has been performed.The report concluded: "damage was observed on the accolade trunnion and v40 head taper.This damage was consistent with a result due to a loss of taper lock between the head taper and the stem trunnion.The stem neck was also damaged, consistent with contact with cup.Damage was observed on the distal rim and the articulating surface of the insert, consistent with its contact with the trunnion.Abrasion, third-body indentations, and scratches were also observed on the articulating surface and are consistent with commonly identified damage modes in uhmwpe inserts.No materials or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿based upon the information available for review, no determination can be made regarding the cause of the apparent loss of the head trunnion taper lock, which led to the disassociation and revision surgery ten years post-implantation.Additional clinical information in addition to x-ray and mri images may be helpful to further understand the reported event.¿ device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the event was confirmed that a disassociation occurred.The root cause could not be confirmed based on the clinician¿s review that, ¿based upon the information available for review, no determination can be made regarding the cause of the apparent loss of the head trunnion taper lock, which led to the disassociation and revision surgery ten years post-implantation.Additional clinical information in addition to x-ray and mri images may be helpful to further understand the reported event.¿.

Event Description

The customer, reported that he revised an accolade stem that had disengaged with the head.The original surgery was done 10 years ago and original post op x-rays looked fine.Patient presented with pain and stated that the affected side never 'felt right' compared to the other side.Update: damage was observed on the distal rim and the articulating surface of the insert, consistent with its contact with the trunnion.Abrasion, third-body indentations, and scratches were also observed on the articulating surface and are consistent with commonly identified damage modes in uhmwpe inserts.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #1
• 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: 6354411
• MDR Text Key: 68174673
• Report Number: 0002249697-2017-00639
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 11/27/2017

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: 03/31/2011
• Device Catalogue Number: 6021-0130
• Device Lot Number: 17348701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: 10/30/2017
• Supplement Dates FDA Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2006
• 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