MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 4; HIP CEMENTLESS STEM

Model Number	01.39.004
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16-jan-2020: lot 157267: (b)(4) items manufactured and released on 10-mar-2016.Expiration date: 24.02.2021.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Preliminary investigation: femoral stem covered in biological fluids, it is not possible to determine any implant's related failure root cause.Other device involved in the event ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 36 size m 0 lot.185180 (k112115).Batch review performed on 16-jan-2020: lot 185180: (b)(4) items manufactured and released on 15-nov-2018.Expiration date: 29.10.2023.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.
Event or Problem Description
Revision surgery due to pain and leg length discrepancy 2 months after primary, the stem was subsided.The stem and the head have been revised.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 4
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9705042
• Report Number: 3005180920-2020-00046
• Device Sequence Number: 17012988
• Product Code: LZO
• UDI-Device Identifier: 07630030885532
• UDI-Public: 07630030885532
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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: 02/24/2021
• Device Model Number: 01.39.004
• Device Catalogue Number: 01.39.004
• Device Lot Number: 157267
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/13/2020
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 90