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
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2023-00829
• Device Sequence Number: 7702584
• Product Code: JDI
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2026
• Device Catalogue Number: 01.12.033
• Device Lot Number: 2010667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Race: White