MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 56 MULTI-HOLE; CEMENTLESS ACETABULAR CUP

Model Number	01.32.156MH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 march 2021: lot 1910276: (b)(4) items manufactured and released on 26-feb-2020.Expiration date: 2025-02-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved: liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721) lot.1910290.Batch review performed 02 march 2021: lot 1910290: (b)(4) items manufactured and released on 29-jan-2020.Expiration date: 2024-12-15, no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar event reported.Additional implant involved: screws: mpact 01.32.6530 cancellous bone screw, flat head ø 6,5 l 30 (k103721) lot.2002265.Batch review performed 02 march 2021: lot 2002265: (b)(4) items manufactured and released on 30-apr-2020.Expiration date: 2025-04-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event reported.Additional implant involved: stem: amistem c 01.18.102 cemented lat stem size 2 (k103189) lot.2000006.Batch review performed 02 march 2021: lot 2000006: (b)(4) items manufactured and released on 19-may-2020.Expiration date: 2025-05-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved: ball heads: cocr 01.25.033 cocr ball head 12/14 ø 36 size xl +7 (k080885) lot.171785.Batch review performed 02 march 2021: lot 171785: (b)(4) items manufactured and released on 31-jul-2017.Expiration date: 2022-07-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.6 months after primary the surgeon performed a washout, removed all components, and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL 56 MULTI-HOLE
• Common Device Name: CEMENTLESS ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11481913
• Report Number: 3005180920-2021-00214
• Device Sequence Number: 14422213
• Product Code: LPH
• UDI-Device Identifier: 07630030810862
• UDI-Public: 07630030810862
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 03/15/2021

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: 02/17/2025
• Device Model Number: 01.32.156MH
• Device Catalogue Number: 01.32.156MH
• Device Lot Number: 1910276
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention