MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3; CEMENTLESS STEM

Model Number 01.12.033

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Unspecified Infection (1930)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21 february 2020: lot 152983: (b)(4) items manufactured and released on 23-set-2015.Expiration date: 2020-09-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported since 2016.Clinical evaluation performed by medical affairs manager: delayed infection in cementless tha, 1 month 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.Additional items invovled in the event, batch review performed on 21 february 2020: cup: versafitcup cc trio 01.26.45.0052 acetabular shell cc trio ø 52 (k103352) lot.1903297.Lot 1903297: (b)(4) items manufactured and released on 05-july-2019.Expiration date: 2024-06-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported.Liner: cc e cc light 01.26.3644hct flat pe hc liner ø 36 / e (k103352) lot.1904384.Lot 1904384: (b)(4) items manufactured and released on 21-june-2019.Expiration date: 2024-06-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported.Ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot.1903858.Lot 1903858: (b)(4) items manufactured and released on 24-july-2019.Expiration date: 2024-07-10.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 Description

Revision surgery performed 1 month after the primary due to an infection.The head, stem and inlay were revised and the pathogen kind is unknown.The stem was loose.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3
• Type of Device: CEMENTLESS 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 9822777
• MDR Text Key: 190333359
• Report Number: 3005180920-2020-00140
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2020
• Device Model Number: 01.12.033
• Device Catalogue Number: 01.12.033
• Device Lot Number: 152983
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2015
• 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