MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.39.202
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 october 2019: lot 166777: (b)(4) items manufactured and released on 26-jan-2017.Expiration date: 2022-01-10.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 manager partial hip revision (stem and head) performed 1 year and 9 months after cementless total hip arthroplasty.No information concerning patient age, activity level and general health status is available.Poor quality of radiographic image provided doesn't allow a proper clinical evaluation.Osseointegration failures may be caused by pre-existing comorbidities or patient characteristics that reduce bone metabolism.The reason of this event cannot be determined.
Event or Problem Description
The patient came in complaining of pain due to no bone ingrowth on the stem.About 1 year and 9 months after primary the surgeon revised successfully the stem and ceramic head.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9233222
• Report Number: 3005180920-2019-00889
• Device Sequence Number: 14074552
• Product Code: LZO
• UDI-Device Identifier: 07630030885624
• UDI-Public: 07630030885624
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 10/24/2019

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: 01/10/2022
• Device Catalogue Number: 01.39.202
• Device Lot Number: 166777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/24/2019
• 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