MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 3 L

Catalog Number	01.13.103R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 march 2018; lot 169044: (b)(4) items manufactured and released on 24 may 2017.Expiration date:2022-05-07 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.Mpact double mobility hc liner 28/dmg reference 01.26.2854mhc (k092265); lot 163188: (b)(4) items manufactured and released on 12 september 2016.Expiration date: 2021-08-23 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.Mectacer biolox delta ceramic ball head 12/14 ø 28 size m 0 reference 01.29.202 (k112115); lot 172250: (b)(4) items manufactured and released on 28 august 2017 expiration date:2022-08-20 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.
Event or Problem Description
The patient came in due to signs of infection.The pathogen is unknown.The surgeon washed out the hip and revised the stem, head and liner.The surgery was completed successfully.

• Brand Name: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 3 L
• Common Device Name: CEMENTLESS ANATOMICAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7344708
• Report Number: 3005180920-2018-00157
• Device Sequence Number: 19246883
• Product Code: LZO
• UDI-Device Identifier: 07630030803208
• UDI-Public: 07630030803208
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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 Expiration Date: 05/07/2022
• Device Catalogue Number: 01.13.103R
• Device Lot Number: 169044
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 03/16/2018
• 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