MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 6; HIP STEM

Catalog Number	01.39.006
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 5 years and 3 months from the primary, the patient came in reporting pain due to a loose stem.The surgeon revised the medacta stem and head with a competitor's products and revised the medacta liner with a medacta liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 16 novemeber 2023.Lot 173196: (b)(4) items manufactured and released on 04-jan-2018.Expiration date: 2022-12-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 6
• Common Device Name: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18267224
• Report Number: 3005180920-2023-00950
• Device Sequence Number: 17164577
• Product Code: LZO
• UDI-Device Identifier: 07630030885556
• UDI-Public: 07630030885556
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2023

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: 12/12/2022
• Device Catalogue Number: 01.39.006
• Device Lot Number: 173196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2018
• 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: Required Intervention
• Patient Sex: Male