MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 00; CEMENTLESS STEM

Catalog Number	01.18.098
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 october 2019: lot 152520: (b)(4) items manufactured and released on 29-sep-2015.Expiration date: 2020-09-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: hip revision surgery performed 3 years after stem implantation.The patient underwent a first revision of the acetabular component 1 year after primary surgery due to suboptimal position of the cup.Radiographic images provided show the presence of radiolucent lines in proximal gruen zones and the stem looks slightly undersized.The reason of this choice is unknown: particular patient anatomy or bone morphology may be a reason but this cannot be determined on the basis of images received.Aseptic loosening is a possible literature described adverse event after cementless total hip arthroplasty and causes are often unknown.The reason of this event cannot be determined.
Event or Problem Description
About 3 years and 2 months after primary the surgeon revised the patient hip for stem loosening.All hardware revised successfully.Between primary and this surgery the patient had another revision for infection on the (b)(6) 2017 where all acetabular components and the ceramic head were revised.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 00
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9260470
• Report Number: 3005180920-2019-00920
• Device Sequence Number: 13923112
• Product Code: LZO
• UDI-Device Identifier: 07630030803765
• UDI-Public: 07630030803765
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

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: 09/12/2020
• Device Catalogue Number: 01.18.098
• Device Lot Number: 152520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/31/2019
• 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: Required Intervention