MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58; DOUBLE MOBILITY ACETABULAR CUP

Model Number	01.32.158MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 11 march 2020: lot 1904336: (b)(4) items manufactured and released on 10-oct-2019.Expiration date: 2024-09-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported events.Additional implant involved: liner: versafitcup dm 01.26.2858mhc double mobility hc liner ø 58/28 (k092265) lot.1904373.Batch review performed by medacta regulatory affairs department on 11 march 2020: lot 1904373: (b)(4) items manufactured and released on 20-jul-2019.Expiration date: 2024-07-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.Additional implant involved: ball heads: mectacer 01.29.203 biolox delta ceramic ball head 12/14 ø 28 size l +3.5 (k112115) lot.1903848.Batch review performed by medacta regulatory affairs department on 11 march 2020: lot 1903848: (b)(4) items manufactured and released on 24-jul-2019.Expiration date: 2024-07-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with two similar reported events.Additional implant involved: stem: sms solid 01.36.050 sms solid stem std size 10 (k181693) lot.1905373.Batch review performed by medacta regulatory affairs department on 11 march 2020: lot 1905373: (b)(4) items manufactured and released on 30-oct-2019.Expiration date: 2024-10-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported events.
Event or Problem Description
The patient came in 2 months after the primary due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the cup, head, liner, and stem.The surgery was completed successfully.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58
• Common Device Name: DOUBLE MOBILITY ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9870914
• Report Number: 3005180920-2020-00195
• Device Sequence Number: 524875
• Product Code: LPH
• UDI-Device Identifier: 07630030861000
• UDI-Public: 07630030861000
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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: 09/28/2024
• Device Model Number: 01.32.158MB
• Device Catalogue Number: 01.32.158MB
• Device Lot Number: 1904336
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/24/2020
• 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