MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED LAT STEM SIZE 0; HIP STEM CEMENTED

Model Number	01.18.100
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The primary surgery was performed on (b)(6) 2019.The revision surgery due to infection was performed on (b)(6) 2019.The surgeon revised successfully the stem and head.The surgeon noticed a re-infection when the patient came to the hospital for a follow-up on (b)(6) 2022.The revision surgery was performed successfully on (b)(6) 2022.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department.Late infection in cemented tha, 3 years after primary operation.Early infection happened after primary surgery treated during the first revision.A re-infection was noticed during a follow-up visit, 3 years after primary surgery.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.Batch review performed on 02 may 2022.Lot 1900031: (b)(4) items manufactured and released on 28-march-2019.Expiration date: 2024-03-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional components revised: ball heads: mectacer 01.29.232h head biolox option ø 36 (k131518) lot.167066: (b)(4) items manufactured and released on 09-dec-2016.Expiration date: 2021-11-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2018.Stem: amistem c 01.18.100 cemented lat stem size 0 (k103189) lot.141489b: (b)(4) items manufactured and released on 10-may-2019.Expiration date: 2024-04-27.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event since 2018.Ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k1121159) lot.1810808: (b)(4) items manufactured and released on 11-mar-2019.Expiration date: 2024-02-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Additional Manufacturer Narrative
The primary surgery was performed on (b)(6) 2019.The revision surgery due to infection was performed on (b)(6) 2019.The surgeon revised successfully the stem and head.The surgeon noticed a re-infection when the patient came to the hospital for a follow-up on (b)(6) 2022.The revision surgery was performed successfully on may 2, 2022 and the surgeon revised only the competitor cup.The lots 1900031 and 167066 reported in the initial report, were not revised.
Event or Problem Description
The primary surgery was performed on (b)(6) 2019.The revision surgery due to infection was performed on (b)(6) 2019.The surgeon revised successfully the stem and head.The surgeon noticed a re-infection when the patient came to the hospital for a follow-up on (b)(6) 2022.The revision surgery was performed successfully on may 2, 2022 and the surgeon revised only the competitor cup.

• Brand Name: STEM: AMISTEM C CEMENTED LAT STEM SIZE 0
• Common Device Name: HIP STEM CEMENTED
• 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: 14496130
• Report Number: 3005180920-2022-00387
• Device Sequence Number: 12309988
• Product Code: LZO
• UDI-Device Identifier: 07630030803789
• UDI-Public: 07630030803789
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: 03/19/2024
• Device Model Number: 01.18.100
• Device Catalogue Number: 01.18.100
• Device Lot Number: 1900031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2019
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian