MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48; CEMENTLESS ACETABULAR CUP

Model Number	01.32.148MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At 4 months after the primary surgery, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 02.Nov.2021: lot 2008060: (b)(4) items manufactured and released on 21-jan-2021.Expiration date: 2025-12-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no similar reported event.Additonal implant involved: liner: mpact dm 01.26.2848mhc double mobility hc liner 28/dmd (k092265) lot.2009650.Batch review performed on 02.Nov.2021: lot 2009650: (b)(4) items manufactured and released on 20-nov-2020.Expiration date: 2025-11-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no similar reported event.Additonal implant involved: stem: amistem-p collared 01.18.432 amistem-p collared std stem size 2 (k173794) lot.2011562.Batch review performed on 02.Nov.2021: lot 2011562: (b)(4) items manufactured and released on 10-feb-2021.Expiration date: 2026-01-27 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no similar reported event.Additonal implant involved: ball heads: mectacer 01.29.243a sleeve size xl (k131518) lot.2007618.Batch review performed on 02.Nov.2021: lot 2007618: (b)(4) items manufactured and released on 6-nov-2020.Expiration date: 2025-10-13 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no similar reported event.Additonal implant involved: ball heads: mectacer 01.29.230h head biolox option ø 28 (k131518) lot.2012928.Batch review performed on 02.Nov.2021: lot 2012928: (b)(4) items manufactured and released on 20-apr-2021.Expiration date: 2026-04-05 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no similar reported event.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
• 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: 12809543
• Report Number: 3005180920-2021-00894
• Device Sequence Number: 11930413
• Product Code: LPH
• UDI-Device Identifier: 07630030860959
• UDI-Public: 07630030860959
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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: 12/27/2025
• Device Model Number: 01.32.148MB
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 2008060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2021
• 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: Male