MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø50 NO-HOLE; CEMENTLESS ACETABULAR CUP

Model Number	01.32.150SH
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 08 march 2022: lot 2106822: (b)(4) items manufactured and released on 27-july-2021.Expiration date: 2026-07-11.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 implant involved: liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot.2108135.Batch review performed on 08 march 2022: lot 2108135: (b)(4) items manufactured and released on 03-aug-2021.Expiration date: 2026-07-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event.Additional implant involved: stem: quadra-p 01.12.254 quadra-p short neck std stem size 4 (k192827) lot.2004666.Batch review performed on 08 march 2022: lot 2004666: (b)(4) items manufactured and released on 10-sept-2020.Expiration date: 2025-08-31.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 implant involved: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.2105978.Batch review performed on 08 march 2022: lot 2105978: (b)(4) items manufactured and released on 09-sept-2021.Expiration date: 2026-08-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event.
Event or Problem Description
At 4 months from primary surgery the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø50 NO-HOLE
• 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: 13947487
• Report Number: 3005180920-2022-00207
• Device Sequence Number: 4309368
• Product Code: LPH
• UDI-Device Identifier: 07630030810787
• UDI-Public: 07630030810787
• 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): 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: 07/11/2026
• Device Model Number: 01.32.150SH
• Device Catalogue Number: 01.32.150SH
• Device Lot Number: 2106822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2021
• 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 Sex: Female