MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 5

Catalog Number	01.13.105R
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	06/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: lot 178979: (b)(6) items manufactured and released on 15-mar-2018.Expiration date: 06-03-2023.No anomalies found related to the problem.To date, 13 items of the same lot have been already sold with one other similar reported event.Clinical evaluation performed by medical affairs manager: femoral revision performed 10 months after cementless total hip arthroplasty in a 65 years old, heavy (100 kg) patients.Reason for revision is a femoral fracture of unknown etiology: a traumatic event or a sudden movement on a weakened bone due to femoral preparation during primary surgery may be possible causes.However, the final cause of this event cannot be determined due to poor quality of radiographic images provided and the absence of the date of examination.
Event or Problem Description
Revision surgery performed 10 months after primary surgery due to a small fracture in proximal femur probably occurred during the primary surgery which caused the stem to slide into a valgus position.The revision surgery was completed and the stem was revised.

• Brand Name: STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 5
• Common Device Name: CEMENTLESS ANATOMICAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8784033
• Report Number: 3005180920-2019-00565
• Device Sequence Number: 14038099
• Product Code: LZO
• UDI-Device Identifier: 07630030803246
• UDI-Public: 07630030803246
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2019

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: 06/03/2023
• Device Catalogue Number: 01.13.105R
• Device Lot Number: 178979
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/12/2019
• 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: 100