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 Device Dislodged or Dislocated (2923); Material Deformation (2976); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision hip performed on (b)(6) 2016.Femoral head was off of femoral trunnion.Replaced accolade tmzf stem with restoration modular stem.

Event Description

Revision hip performed on (b)(6) 2016.Femoral head was off of femoral trunnion.Replaced accolade tmzf stem with restoration modular stem.

Manufacturer Narrative

An event regarding alleged "disassociation" involving an accolade stem was reported.The event was confirmed.Method & results: device evaluation and results: material analysis was performed and concluded that "damage was observed on the accolade trunnion and v40 head taper.This damage was consistent with wear mechanisms due to the head taper and accolade stem trunnion losing their taper lock.Scratches were observed on the insert, which is a common damage mode of uhmwpe.Yellow discoloration consistent with absorption of synovial fluid was also observed on the insert.Eds showed the head is consistent with astm f1537 and the debris was consistent with a corrosion product and biological material.No material defects were observed on the surfaces examined." medical records received and evaluation: a review of the provided primary and revision operative reports, and x-ray printouts by the consulting clinician indicated that "[.]" based upon the information available for review, no determination can be made regarding the cause of this clinical event." device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event was confirmed based on the material analysis report dated (b)(6) 2017 stating "the conclusions of this report are: (1) damage was observed on the stem trunnion and v-40 head taper, which was consistent with wear mechanisms due to head taper and accolade stem trunnion losing their taper lock; [.] "(4) eds showed the head base material was consistent with the expected alloy and the debris consistent with a corrosion product and biologic material; and (5) no material defects were observed." additionally, a review of the provided primary and revision operative reports and x-ray printouts by a clinical consultant indicated: "based upon the information available for review, no determination can be made regarding the cause of this clinical event." if additional information are received, this investigation will be reopened and re-evaluated.

• 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
• MDR Report Key: 6212472
• MDR Text Key: 63502081
• Report Number: 0002249697-2016-04040
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Catalogue Number: 6021-0537
• Device Lot Number: 23256601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Date Manufacturer Received: 01/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 112