MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.18.144
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 march 2018; lot 155664: (b)(4) items manufactured and released on 26 jan 2016.Expiration date: 2021-01-12 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 40 size s - 4 reference 01.29.212 (k112115) lot 124375: (b)(4) items manufactured and released on 17 jan 2013 expiration date: 2017-12-31 no anomalies found related to the problem.To date, (b)(4)items of the same lot have been sold without any similar reported event.
Event or Problem Description
Medacta international was informed on (b)(6) 2018 by the sales agent that the patient came in due to signs of infection.The pathogen is unavailable.The surgeon removed on (b)(6) 2018 implants and implant a spacer.The surgery was completed successfully.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7326621
• Report Number: 3005180920-2018-00127
• Device Sequence Number: 16169021
• Product Code: LZO
• UDI-Device Identifier: 07630030804205
• UDI-Public: 07630030804205
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

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: 01/12/2021
• Device Catalogue Number: 01.18.144
• Device Lot Number: 155664
• 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: 02/07/2018
• Initial Report FDA Received Date: 03/09/2018
• 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