MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H 01.12.033 CEMENTLESS, HA COATED LAT STEM SIZE 3; HIP CEMENTLESS, HA COATED LAT STEM

Catalog Number 01.12.033

Device Problems Device Appears to Trigger Rejection (1524); Osseointegration Problem (3003)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646)

Event Date 09/28/2023

Event Type  Injury  

Event Description

At about 1 year after the primary, the patient has been revised because of a citrobacter koseri infection and stem loosening.All implants were removed and a g spacer has been put in place.

Manufacturer Narrative

Batch review performed on 04-oct-2023.Lot 2010667: (b)(4) items manufactured and released on 03-feb-2021.Expiration date: 2026-01-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Other devices involved: batch review performed on 04-oct-2023: cup: versafitcup cc trio 01.26.45.0054 acetabular shell cc trio ø 54 (k103352) lot 2200445: (b)(4)items manufactured and released on 05-apr-2022.Expiration date: 2027-03-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 2204282: (b)(4) items manufactured and released on 19-may-2022.Expiration date: 2027-05-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.Liner: mectacer 01.29.413 ceramic liner ø 36 / e (device not distributed in us) lot 2117207: (b)(4)items manufactured and released on 08-mar-2022.Expiration date: 2027-02-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: STEM: QUADRA-H 01.12.033 CEMENTLESS, HA COATED LAT STEM SIZE 3
• Type of Device: HIP CEMENTLESS, HA COATED LAT 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18020076
• MDR Text Key: 326697240
• Report Number: 3005180920-2023-00829
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/27/2023

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 Catalogue Number: 01.12.033
• Device Lot Number: 2010667
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/03/2021
• 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: 64 YR
• Patient Sex: Male
• Patient Race: White