MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE HFX SIZE #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6077-0230
Medical Device Problem Codes	Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	03/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding subsidence involving an accolade stem was reported.The event was confirmed by medical review.Method & results: product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿in this (b)(6) patient, failure to gain biologic fixation with early post­ operative evidence of stem subsidence progressed to further subsidence resulting in impingement of the host femoral neck and the unitrax head, which ultimately resulted in disassociating it from the trunnion.Subsequent revision to a cemented stem construct will prevent a recurrence of this scenario.Examination of the explanted components would confirm this mechanism and rule out factors associated with implant manufacturing or materials as contributing to this event.¿ product history review: review of the product 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 of subsidence was confirmed by the clinician¿s review.The clinician¿s review stated, ¿in this (b)(6) patient, failure to gain biologic fixation with early post­operative evidence of stem subsidence progressed to further subsidence resulting in impingement of the host femoral neck and the unitrax head, which ultimately resulted in disassociating it from the trunnion.Subsequent revision to a cemented stem construct will prevent a recurrence of this scenario.Examination of the explanted components would confirm this mechanism and rule out factors associated with implant manufacturing or materials as contributing to this event.¿.
Event or Problem Description
It was reported by patient's attorney that the patient was implanted with a stryker hip system and underwent revision surgery.Update: on (b)(6) 2017 a right hip hemiarthroplasty revision and removal of femoral head and reimplantation of a bipolar hip arthroplasty was performed for a pre-operative diagnosis of "failed right hip hemiarthroplasty.With right hip disassociation from unitrax head component.And possible loosening.In this (b)(6) patient, failure to gain biologic fixation with early post­operative evidence of stem subsidence progressed to further subsidence resulting in impingement of the host femoral neck and the unitrax head, which ultimately resulted in disassociating it from the trunnion.

• Brand Name: ACCOLADE HFX SIZE #2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7823064
• Report Number: 0002249697-2018-02691
• Device Sequence Number: 1536017
• Product Code: LPH
• UDI-Device Identifier: 07613327021189
• UDI-Public: 07613327021189
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 6077-0230
• Device Lot Number: M000WH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 95