MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 56 TWO-HOLES

Model Number	01.12.023
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020: lot 178262: 120 items manufactured and released on (b)(6) 2018.Expiration date: 2023-03-19.No anomalies found related to the problem.To date, 110 items of the same lot have been already sold without another 1 similar reported event.Other devices involved in the event liner: impact 01.32.3648hct flat pe hc liner ø36/f lot.166667 (k103721) batch review performed on (b)(6) 2020: lot 166667: 77 items manufactured and released on 13-dec-10§6.Expiration date: 2011-11-27.No anomalies found related to the problem.To date, 74 items of the same lot have been already sold without any similar reported event ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 lot.176376 (k112115) batch review performed on (b)(6) 2020: lot 176376: 220 items manufactured and released on (b)(6) 2018.Expiration date: 2022-12-22.No anomalies found related to the problem.To date, 22 items of the same lot have been already sold with another similar reported event.Stem: quadra-h 01.12.034 cementless, ha coated lat stem # 4 lot.174068 (k082792) batch review performed on (b)(6) 2020: lot 174068: 39 items manufactured and released on (b)(6) 2017.Expiration date: 2022-11-06.No anomalies found related to the problem.To date, 37 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
1 year and 2 months after primary, revision surgery performed due to infection.Right side.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL 56 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10593620
• Report Number: 3005180920-2020-00667
• Device Sequence Number: 11745906
• Product Code: LPH
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2020

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: 03/19/2023
• Device Model Number: 01.12.023
• Device Catalogue Number: 01.32.156DH
• Device Lot Number: 178262
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/28/2020
• 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: 74 YR