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

Model Number	6021-0230
Medical Device Problem Codes	Material Erosion (1214); Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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 or Problem Description
In 2013, the patient underwent tha procedure with mdm and accolade tmzf.Then, the neck of the stem has scraped due to the rear impingement.On (b)(6) 2020, the revision surgery is scheduled.***request***please identify based on your investigation what is line of between the polyethylene and the neck, which is on the necked part of the complaint product.
Additional Manufacturer Narrative
An event regarding wear involving an accolade stem was reported.The event was confirmed.Method & results: device evaluation and results: the provided photograph shows a recently explanted accolade stem reduced into mdm poly with 1 cm deep notch at base of superior neck approx.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: undated, unlabelled photo of explanted femoral stem reduced into mdm poly with 1 cm deep notch at base of superior neck approx.1 cm proximal to trunnion.Undated, unlabelled x-rays ap pelvis, lateral left hip demonstrating a hybrid left tha, reduced, nominal position with a notch at the stem base visible on the lateral x-ray.No clinical or pmh, no patient demographics, no operative reports, no examination of explanted components, no dated serial x-rays.Implant photo and x-ray confirms impingement defect noted in event description, but insufficient data is presented to create a medical report.Device 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.Conclusion: the provided photo of explanted accolade stem reduced into mdm poly with 1 cm deep notch at base of superior neck approx.1 cm proximal to trunnion.Unlabelled x-rays ap pelvis, lateral left hip demonstrating a hybrid left tha, reduced, nominal position with a notch at the stem base visible on the lateral x-ray.Explanted device photo and provided x-rays confirms impingement defect noted in event description.
Event or Problem Description
In 2013, the patient underwent tha procedure with mdm and accolade tmzf.Then, the neck of the stem has scraped due to the rear impingement.On (b)(6) 2020, the revision surgery is scheduled.Request: please identify based on your investigation what is line of between the polyethylene and the neck, which is on the necked part of the complaint product.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #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: 10072619
• Report Number: 0002249697-2020-00955
• Device Sequence Number: 14390796
• Product Code: LPH
• UDI-Device Identifier: 04546540510679
• UDI-Public: 04546540510679
• Combination Product (Y/N): N
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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: 05/31/2018
• Device Model Number: 6021-0230
• Device Catalogue Number: 6021-0230
• Device Lot Number: 43451803
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 07/24/2020
• 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