MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES; CEMENTLESS ACETABULAR CUP

Model Number	01.32.152DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04-mar-2022: lot 1903421: (b)(4) items manufactured and released on 29-jul-2019.Expiration date: 2024-07-15.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been already sold without other similar reported events.Additional implant involved: liner: mectacer 01.29.413 ceramic liner ø 36 / e (not registered in usa) lot.1903875: batch review performed on 04-mar-2022: lot 1903875: (b)(4) items manufactured and released on 26-jul-2019.Expiration date: 2024-07-14.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Additional implant involved: stem: quadra-h 01.12.033 cementless, ha coated lat stem size 3 (k082792) lot.187837: batch review performed on 04-mar-2022: lot 187837: (b)(4) items manufactured and released on 06-feb-2019.Expiration date: 2024-01-07.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been already sold without other similar reported events.Additional implant involved: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot.1902999: batch review performed on 04-mar-2022: lot 1902999: (b)(4) items manufactured and released on 12-jul-2019.Expiration date: 2024-06-29.No anomalies were found related to the problem.To date, all items of the same lot have been already sold without other similar reported events.Clinical evaluation performed by medical affairs department: late infection in cementless tha, 2 years after primary operation in a (b)(6) year old patient.Patient reported pain and instability in the articulation.Radiographic images provided, show cyst formation in the lateral dyaphisis which may be caused by the infection.All implants were removed and a spacer was inserted.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.
Event or Problem Description
Revision surgery was performed due to cyst formation and loosening of the femoral component, secondary to infection.The first stage revision was completed almost 2 years and 4 months after primary, all components were removed and the cement spacer was inserted.Stage two is to be completed at a later stage.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES
• Common Device Name: CEMENTLESS ACETABULAR CUP
• 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: 13947494
• Report Number: 3005180920-2022-00205
• Device Sequence Number: 14605442
• Product Code: LPH
• UDI-Device Identifier: 07630030810794
• UDI-Public: 07630030810794
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 03/30/2022

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: 07/15/2024
• Device Model Number: 01.32.152DH
• Device Catalogue Number: 01.32.152DH
• Device Lot Number: 1903421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2019
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White