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

Model Number	01.32.152DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 september 2020: lot 1907399: (b)(4) items manufactured and released on 04-dec-2019.Expiration date: 2024-11-24.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.Clinical evaluation: infection in hybrid tha occurred after repeated surgeries in a (b)(6) year-old woman.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Other devices involved in the event: screws: mpact 01.32.6535 cancellous bone screw, flat head ø 6,5 l 35 lot.1905815 (k103721).Batch review performed on 09 september 2020: lot 1905815: (b)(4) items manufactured and released on 14-aug-2019.Expiration date: 2024-07-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.Liner: mpact 01.32.3644hct flat pe hc liner ø36/e lot.1905500 (k103721).Batch review performed on 09 september 2020: lot 1905500: (b)(4) items manufactured and released on 03-jul-2019.Expiration date: 2024-06-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.Stem: quadra -r 01.12.062 cementless, ha coated revision stem # 2 lot.1905457 (k082792).Batch review performed on 09 september 2020: lot 1905457: (b)(4) items manufactured and released on 21-jan-2020.Expiration date: 2025-01-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.Ball heads: mectacer 01.29.211 biolox delta ceramic ball head 12/14 ø 36 size xl +8 lot.1907363 (k112115).Batch review performed on 09 september 2020: lot 1907363: (b)(4) items manufactured and released on 20-nov-2019.Expiration date: 2024-11-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.
Event or Problem Description
The patient had a surgery in (b)(6) 2020 due to femur fracture, fixed without using medacta implants.On (b)(6) 2020 the patient was revised to convert the fracture fixation in a tha, medacta implants were used.On (b)(6) 2020 the patient has been revised due to infection.All devices revised.

• Brand Name: CUP: MPACT ACETABULAR SHELL 52 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10535329
• Report Number: 3005180920-2020-00606
• Device Sequence Number: 372520
• Product Code: LPH
• UDI-Device Identifier: 07630030810794
• UDI-Public: 07630030810794
• Combination Product (Y/N): Y
• Initial Reporter Country: IS
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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: 11/24/2024
• Device Model Number: 01.32.152DH
• Device Catalogue Number: 01.32.152DH
• Device Lot Number: 1907399
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/15/2020
• 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: 76 YR
• Patient Weight: 76