MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5 LOT. 184057; UNCEMENTED HIP STEM

Catalog Number	01.13.105L
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 1 july 2019: lot 184057: (b)(4) items manufactured and released on 18-set-2018.Expiration date: 2023-09-09.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.Additional device involved: ball heads: mectacer 01.29.206 biolox delta ceramic ball head 12/14 ø 32 size l +4 (k112115) lot.177695: (b)(4) items manufactured and released on 27-feb-2018.Expiration date: 2023-02-13.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.Clinical evaluation performed by medical affairs department manager: few weeks after cementless total hip arthroplasty, the patient reported pain due to a femoral fracture.During rehabilitation period, a sudden movement on a weakened bone due to normal femoral preparation may favour the occurrence of early fracture.There is no reason to suspect a faulty device.
Event or Problem Description
Revision surgery performed 14 days after the primary due to pain caused by a fractured femur and subsided stem (the cause of the fracture is unknown).The surgeon revised the stem and the head and cabled the fracture.The surgery was completed successfully.

• Brand Name: STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5 LOT. 184057
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8757404
• Report Number: 3005180920-2019-00527
• Device Sequence Number: 19403244
• Product Code: LZO
• UDI-Device Identifier: 07630030803239
• UDI-Public: 07630030803239
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2019

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: 09/09/2023
• Device Catalogue Number: 01.13.105L
• Device Lot Number: 184057
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 07/03/2019
• 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