MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-P LAT STEM SIZE 4; CEMENTLESS HIP STEM

Model Number	01.12.144
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Left hip revision surgery 5 months after the primary surgery due to infection.Cup, liner, head, and stem revised.
Additional Manufacturer Narrative
Batch review performed on 27 october 2021.Lot 1907008: (b)(4) items manufactured and released on 08-jan-2020.Expiration date: 2024-dec-16.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 items involved in the event, batch review performed on 27 october 2021.Ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot.2006698.Lot 2006698: (b)(4) items manufactured and released on 09-oct-2020.Expiration date: 2025-sep-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.Mpact 01.32.156sh acetabular shell ø56 no-hole (k132879) lot.2009447.Lot 2009447: (b)(4) items manufactured and released on 26-jan-2021.Expiration date: 2026-jan-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721) lot.2009614.Lot 2009614: (b)(4) items manufactured and released on 10-nov-2020.Expiration date: 2025-oct-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: STEM: QUADRA-P LAT STEM SIZE 4
• Common Device Name: CEMENTLESS HIP 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: 12874256
• Report Number: 3005180920-2021-00907
• Device Sequence Number: 19921694
• Product Code: LZO
• UDI-Device Identifier: 07630040720564
• UDI-Public: 07630040720564
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2021

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: 12/16/2024
• Device Model Number: 01.12.144
• Device Catalogue Number: 01.12.144
• Device Lot Number: 1907008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2020
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White