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

Model Number	01.39.206
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 march 2021: lot 177969: (b)(4) items manufactured and released on 21-mar-2018.Expiration date: 2023-03-12.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.
Event or Problem Description
Immediately after the primary hip surgery, when the surgeon took post-op x-rays, it was observed that the patient had a misplaced femoral component.The surgeon decided to revise the patient immediately and swapped the stem and head with competitor implants and the medacta liner with a medacta liner.The surgery was completed successfully.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT SIZE 6
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11699788
• Report Number: 3005180920-2021-00310
• Device Sequence Number: 3499512
• Product Code: LZO
• UDI-Device Identifier: 07630030885662
• UDI-Public: 07630030885662
• 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: 2021
• Device Explanted Year: 2021
• 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): 04/21/2021

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: 03/12/2023
• Device Model Number: 01.39.206
• Device Catalogue Number: 01.39.206
• Device Lot Number: 177969
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/21/2021
• 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: 69 YR
• Patient Weight: 91