MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE

Model Number	01.32.152MH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The primary hip surgery on (b)(6) 2020.On (b)(6) 2021, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon performed a washout and revised the cup, head, and liner.The surgery was completed successfully.Presently, on (b)(6) 2022, at 7 months from the precedent surgery, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon revised the medacta cup, liner and head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 01 february 2022: lot 2005096: (b)(4) items manufactured and released on 09-nov-2020.Expiration date: 2025-10-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional items involved in the event, batch review performed on 01 february 2022: liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot.2013103.Lot 2013103: (b)(4) items manufactured and released on 13-jan-2021.Expiration date: 2025-12-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2009405.Lot 2009405: (b)(4) items manufactured and released on 19-jan-2021.Expiration date: 2026-01-03.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
Batch review performed on 01 february 2022: lot 2005096: (b)(4) items manufactured and released on 09-nov-2020.Expiration date: 2025-10-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional items involved in the event, batch review performed on 01 february 2022: liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot.2013103.Lot 2013103: (b)(4) items manufactured and released on 13-jan-2021.Expiration date: 2025-12-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2009405.Lot 2009405: (b)(4) items manufactured and released on 19-jan-2021.Expiration date: 2026-01-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The primary hip surgery on (b)(6) 2020.On (b)(6) 2021, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon performed a washout and revised the cup, head, and liner.The surgery was completed successfully.Presently, on (b)(6) 2022, at 7 months from the precedent surgery, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon revised the medacta cup, liner and head.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE
• Common Device Name: ACETABULAR SHELL
• 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: 13584648
• Report Number: 3005180920-2022-00133
• Device Sequence Number: 14930869
• Product Code: LPH
• UDI-Device Identifier: 07630030810800
• UDI-Public: 07630030810800
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 02/23/2022

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: 10/29/2025
• Device Model Number: 01.32.152MH
• Device Catalogue Number: 01.32.152MH
• Device Lot Number: 2005096
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2020
• 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 Sex: Male