MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-0435

Device Problems Degraded (1153); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Ossification (1428); Discomfort (2330); Injury (2348)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding altr & disassociation involving an accolade stem was reported.Disassociation was confirmed as a result of a mar.Altr was not confirmed.Method & results: product evaluation and results: a visual inspection was performed by a material analysis engineer which noted; the anterior, posterior, superior and inferior surfaces of the stem, respectively.All surfaces of the neck exhibited damage, consistent with wear mechanisms due to the head taper and stem trunnion losing their taper lock.Biological fixation and explantation damage were also observed on the stem.A material analysis concluded; damage was observed on the stem trunnion and head taper.This damage was consistent with wear mechanisms due to the head taper and the stem trunnion losing their taper lock.Scratches were observed on the insert, which is a common damage mode of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant noted; the mar confirms there were no device-related matters present although otherwise the cause of the problem remains obscure due to lack of information although i am not sure whether additional clinical information would solve the problem.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including office/clinical notes, histopathology and serial x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

The patient had increasing discomfort in this right hip in fall and since (b)(6).The x-ray image of (b)(6) 2017 (lumbar spine ap with hip cut) shows a concentric situation and a correctly placed head on the cone of the right hip.On (b)(6) 2018, misalignment of the head on the cone and visible ossification, could be seen on x-ray image for the first time; abrasion.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #4
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7942455
• MDR Text Key: 123056488
• Report Number: 0002249697-2018-03227
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540510693
• UDI-Public: 04546540510693
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/08/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2009
• Device Catalogue Number: 6021-0435
• Device Lot Number: 9656302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2004
• 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
• Patient Age: 73 YR
• Patient Weight: 76