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

Catalog Number 01.18.134

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 09 may 2018.Lot 160737: 100 items manufactured and released on 18 may 2016.Expiration date: 2021-05-02.No anomalies found related to the problem.To date,96 items of the same lot have been already sold without any similar reported event.Cocr ball head 12/14 ø 36, size s -3.5 reference ((b)(4)).Lot 157529: 55 items manufactured and released on 01 march 2016.Expiration date: 2021-02-16.No anomalies found related to the problem.To date, 43 items of the same lot have been already sold without any similar reported event mpact acetabular shell ø58 two-holes reference ((b)(4)).Lot 135877: 49 items manufactured and released on 07 august 2014.Expiration date: 2019-06-30.No anomalies found related to the problem.To date, 46 items of the same lot have been already sold without any similar reported event.Mpact flat pe hc liner ø36/f reference ((b)(4)).Lot 140555: 70 items manufactured and released on 17 april 2014.Expiration date: 2019-02-28.No anomalies found related to the problem.To date, 67 items of the same lot have been already sold without any similar reported event.Mpact cancellous bone screw, flat head ø 6,5 l 15 reference (b)(4).Lot 115662: 150 items manufactured and released on 09 april 2012.Expiration date: 2017-02-28.No anomalies found related to the problem.To date, 64 items of the same lot have been already sold without any similar reported event mpact cancellous bone screw, flat head ø 6,5 l 20 reference (b)(4).Lot 115663: 299 items manufactured and released on 03 april 2012.Expiration date: 2017-02-28.No anomalies found related to the problem.To date, 212 items of the same lot have been already sold without any similar reported event.

Event Description

On (b)(4) 2018 the sales agent informed medacta that a patient came in due to signs of infection.The surgeon plans to remove all hardware and implant a spacer on (b)(6) 2018.On (b)(4) 2018 medacta was informed that the surgery was completed on (b)(6) 2018.The surgeon removed all hardware and implanted a spacer.The pathogen is unknown.The surgery was completed successfully.

• Brand Name: AMISTEM H HA COATED STD STEM SIZE 4
• Type of Device: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7498743
• MDR Text Key: 107736913
• Report Number: 3005180920-2018-00312
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804106
• UDI-Public: 07630030804106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2021
• Device Catalogue Number: 01.18.134
• Device Lot Number: 160737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention