MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ACETABULAR SHELL CC TRIO NO-HOLE Ø 50

Catalog Number 01.26.45.1150

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 13 april 2018: versafitcup cc trio reference 01.26.45.1150 (k122911) acetabular shell cc trio no-hole ø 50 l.(b)(4).Reference 01.26.3244hct (k103352) flat pe hc liner ø 32 / e.(b)(4).Amistem h reference 01.18.130(k093944) ha coated std stem size 0.(b)(4).Ceramic ball head (not marketed in us): no anomaly found on the document review.Clinical evaluation performed by medical affairs director on 20 april 2018.Late infection in cementless tha, 3 years after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.

Event Description

Revision surgery due to infection with propioni bacteria 3 years after primary.

• Brand Name: ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
• Type of Device: ACETABULAR SHELL
• 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: 7446809
• MDR Text Key: 106062739
• Report Number: 3005180920-2018-00252
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030807886
• UDI-Public: 07630030807886
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K122911
• 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: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 01.26.45.1150
• Device Lot Number: 150073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2015
• 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
• Patient Age: 54 YR