MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES

Model Number	01.32.150DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 september 2020: lot 1902268: (b)(4) items manufactured and released on 18-july-2019.Expiration date: 2024-07-06.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 01.32.3241hct flat pe hc liner ø32/d (k103721) lot.187906.Batch review performed on 10 september 2020: lot 187906: (b)(4) items manufactured and released on 21-nov-2018.Expiration date: 2023-11-07.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: stem: amistem h 01.18.134 ha coated std stem size 4 (k093944) lot.173437.Batch review performed on 10 september 2020: lot 173437: (b)(4) items manufactured and released on 05-sept-2017.Expiration date: 2022-08-22.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
6 months after primary revision surgery performed due to infection.Left side.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10612283
• Report Number: 3005180920-2020-00666
• Device Sequence Number: 2729954
• Product Code: LPH
• UDI-Device Identifier: 07630030810763
• UDI-Public: 07630030810763
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• 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): 10/01/2020

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: 07/06/2024
• Device Model Number: 01.32.150DH
• Device Catalogue Number: 01.32.150DH
• Device Lot Number: 1902268
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 10/01/2020
• 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
• Patient Age: 67 YR