MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5; HIP CEMENTLESS STEM

Model Number	01.13.105L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03-feb-2020: lot 177635: (b)(4) items manufactured and released on 23-jan-2018.Expiration date: 2016-01-23.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.
Event or Problem Description
Revision surgery performed 3 days after primary due to hip dislocation (head from liner, ceramic on ceramic) probably due to stem sinking.The minimax stem was removed and a cemented x-acta short was implanted.The patient was operated in primary due to bone femur fracture.

• Brand Name: STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9738554
• Report Number: 3005180920-2020-00086
• Device Sequence Number: 1815261
• Product Code: LZO
• UDI-Device Identifier: 07630030803239
• UDI-Public: 07630030803239
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 02/21/2020

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: 01/23/2016
• Device Model Number: 01.13.105L
• Device Catalogue Number: 01.13.105L
• Device Lot Number: 177635
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2020
• Initial Report FDA Received Date: 02/21/2020
• 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: 51 YR
• Patient Weight: 90