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 05/07/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 16 may 2018; lot 130678: (b)(4) items manufactured and released on 10 may 2013.Expiration date: 2018-04-30 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.Other devices involed: mectacer biolox delta ceramic ball head 12/14 ø 28 size m 0 reference 01.29.202 (k112115); lot 125618: (b)(4) items manufactured and released on 07 march 2013.Expiration date: 2018-01-31; no anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Versafitcup acetabular shell ø 52 reference 01.26.52mb (k083116); lot 130119: (b)(4) items manufactured and released on 18 april 2013 expiration date: 2018-03-31 no anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Versafitcup dm double mobility hc liner ø 52/28 reference 01.26.2852mhc (k092265); lot 130093: (b)(4) items manufactured and released on 08 march 2013.Expiration date: 2018-01-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.

Event Description

The patient came in due to signs of infection 4 years and 7 months after primary.The surgeon plans to revise the patient on (b)(6) 2018.On (b)(6) 2018 we were informed that the surgeon removed all hardware and implanted another company's product.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, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7525815
• MDR Text Key: 108638541
• Report Number: 3005180920-2018-00347
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2018

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: 04/30/2018
• Device Catalogue Number: 01.18.134
• Device Lot Number: 130678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention