MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.13.104L
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 november 2018: lot 180805: (b)(4) items manufactured and released on 28 may 2018.Expiration date: 2032-05-15.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by "clinial" affairs director: hip revision surgery occurred 2 months after primary cementless total hip arthroplasty.Reason for revision is a femoral fracture probably occurred during postoperative rehabilitation.In this period of time, accidental trauma or sudden movements on a weakened bone due to the normal intraoperative femoral preparation may facilitate fracture occurrence.There is no reason to suspect a faulty device.
Event or Problem Description
Revision surgery performed 2 months after primary due to bone femur fracture.The surgeon revised the stem, head and liner.

• Brand Name: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8077512
• Report Number: 3005180920-2018-00907
• Device Sequence Number: 1887737
• Product Code: LZO
• UDI-Device Identifier: 07630030803215
• UDI-Public: 07630030803215
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2018

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 Catalogue Number: 01.13.104L
• Device Lot Number: 180805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/16/2018
• 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