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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	03/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor revised a v-40 l-fit head 36 +5, replaced by a biolox c-tpr head with a sleeve.Per medical records received: the patient was revised due to elevated metal ion levels and was otherwise asymptomatic.The femoral head and liner were revised.
Additional Manufacturer Narrative
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 remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: "the patient underwent an uncomplicated primary total hip arthroplasty in 2006.Am accolade stem with v-40 metal head was implanted along with a competitor cup.In 2013 he presented to his surgeon after being notified that the femoral head used in this procedure was under recall.The surgeon initiated a workup looking for any issues.An mri showed a large effusion but no other destructive processes.Serology revealed elevated metal ions.On (b)(6) 2017 the patient underwent a revision head and liner exchange.Finds at the time of surgery included a large cloudy effusion and a crack in the posterior aspect of the acetabular liner.No metallosis or evidence of pseudotumor was present.Abductors were intact.Upon removal of the femoral head the trunnion was intact and without damage.A new head, sleeve and liner were placed.It is confirmed that a styker v-40 head a and a competitor liner were revised.The root cause of the liner failure cannot be determined from the documentation provided." product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to elevated metal ion levels.A review of the provided medical records by a clinical consultant as unable to confirm the event.Additional documentation such as return of the device, pathology reports, and pre- and post-operative x-rays as well as patient history and follow-up notes 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.H3 other text: device not returned.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #4
• Common Device Name: 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 ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19249168
• Report Number: 0002249697-2024-00684
• Device Sequence Number: 6397033
• Product Code: LPH
• UDI-Device Identifier: 04546540510693
• UDI-Public: 04546540510693
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K994366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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: 01/31/2011
• Device Catalogue Number: 6021-0435
• Device Lot Number: 16607501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male