MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 52 TWO-HOLES; ACETABULAR CUP

Model Number	01.32.152DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 october 2020: lot 1908321: (b)(4) items manufactured and released on 11-dec-2019.Expiration date: 2024-12-02.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 01.32.3644hct flat pe hc liner 36/e (k103721) lot.1910288.Batch review performed on 06 october 2020: lot 1910288: (b)(4) items manufactured and released on 02-jan-2020.Expiration date: 2024-12-09.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: screws: mpact 01.32.6530 cancellous bone screw, flat head 6,5 l 30 (k103721) lot.2002265.Batch review performed on 06 october 2020: 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 without any similar reported event.Additional implant involved: stem: amistem p 01.18.402 amistem-p std stem size 2 (k173794) lot.1909804.Batch review performed on 06 october 2020: lot 1909804: (b)(4) items manufactured and released on 24-mar-2020.Expiration date: 2025-03-15.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 involed: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 36 size m 0 (k112115) lot.1907359.Batch review performed on 06 october 2020: lot 1907359: (b)(4) items manufactured and released on 08-jan-2020.Expiration date: 2024-12-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.
Event or Problem Description
The patient came in, 15 days after primary surgery, due to signs of infection and the pathogen is unknown.The surgeon performed an i&d, explanted all implants, and replaced them with new implants.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL 52 TWO-HOLES
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10726584
• Report Number: 3005180920-2020-00740
• Device Sequence Number: 14289196
• Product Code: LPH
• UDI-Device Identifier: 07630030810794
• UDI-Public: 07630030810794
• 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: 2020
• 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): 10/23/2020

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: 12/02/2024
• Device Model Number: 01.32.152DH
• Device Catalogue Number: 01.32.152DH
• Device Lot Number: 1908321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2020
• Initial Report FDA Received Date: 10/23/2020
• 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