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

Catalog Number	01.13.104L
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 july 2019: lot 185952: (b)(4) items manufactured and released on 10-"dic"-2018.Expiration date: 25-11-2023.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one other similar reported event.
Event or Problem Description
Revision surgery performed 15 days after the primary due to pain caused by a fractured femur, which occurred while putting on his pants(no fall occurred, the patient placed body weight on one leg while attempting to place the other leg in pant leg when pop was heard and pain occurred).The surgeon cabled the fracture and revised the stem and head.The surgery was completed successfully.

• Brand Name: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 4
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8816677
• Report Number: 3005180920-2019-00615
• Device Sequence Number: 14074707
• Product Code: LZO
• UDI-Device Identifier: 07630030803215
• UDI-Public: 07630030803215
• 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): 07/23/2019

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: 11/25/2023
• Device Catalogue Number: 01.13.104L
• Device Lot Number: 185952
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/23/2019
• 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: 67 YR