MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 6; CEMENTLESS HIP STEM

Model Number	01.13.106R
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 (b)(6) 2020: lot 1905536: (b)(4) items manufactured and released on 11-dic-2019.Expiration date: 2024-12-01.No anomalies found related to the problem.To date, 3 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The post-op x-rays taken after surgery indicated that the stem was undersized.The surgeon decided to operate on the patient again (the same day of primary surgery) and revised the stem size 6 right with a size 7 right and the ceramic head.The surgery was complete successfully.

• Brand Name: STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 6
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10612279
• Report Number: 3005180920-2020-00657
• Device Sequence Number: 16826764
• Product Code: LZO
• UDI-Device Identifier: 07630030803260
• UDI-Public: 07630030803260
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

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: 12/01/2024
• Device Model Number: 01.13.106R
• Device Catalogue Number: 01.13.106R
• Device Lot Number: 1905536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 10/01/2020
• 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