MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE TMZF PLUS #3 STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_SHC

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Inflammation (1932); Reaction (2414)

Event Date 09/29/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

As reported in medwatch # mw5090176: "surgeon did second revision and replaced with stryker lfit v40 femoral head.Since then my cobalt serum levels have risen from 1.6 to 2.2 in 6 months.Surgeon called me friday and said he thinks we need to remove whole implant, stem and all.".

Manufacturer Narrative

Reported event an event regarding abnormal ion level involving an accolade stem was reported.The event was not confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, the one lab test provided shows modest elevation but can't confirm it relates to stryker implant, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-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 lot referenced.Conclusions: the event could not be confirmed.A review of the provided medical showed modest elevation but can't confirm it relates to stryker implant as the patient also had competitors products implanted.Further information such as primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

As reported in medwatch # mw5090176: "surgeon did second revision and replaced with stryker lfit v40 femoral head.Since then my cobalt serum levels have risen from 1.6 to 2.2 in 6 months.Surgeon called me friday and said he thinks we need to remove whole implant, stem and all.".

• Brand Name: UNKNOWN ACCOLADE TMZF PLUS #3 STEM
• 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: 9340572
• MDR Text Key: 167181965
• Report Number: 0002249697-2019-03813
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 82