MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES; CEMENTLESS ACETABULAR CUP

Model Number	01.32.150DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 30.Dec.2021: lot 1907397: (b)(4) items manufactured and released on 28-nov-2019.Expiration date: 2024-11-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event.Additional implant involved: liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot.1902883.Batch review performed by medacta regulatory affairs department on 30.Dec.2021: lot 1902883: (b)(4) items manufactured and released on 08-may-2019.Expiration date: 2024-04-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event.Additional implant involved: ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot.1907339.Batch review performed by medacta regulatory affairs department on 30.Dec.2021: lot 1907339: (b)(4) items manufactured and released on 8-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 sold without any similar reported event.Additional implant involved: stem: masterloc 01.39.203 cementless ti coated lat stem size 3 (k160289) lot.166778c.Batch review performed by medacta regulatory affairs department on 30.Dec.2021: lot 166778c: (b)(4) items manufactured and released on 20-apr-2020.Expiration date: 2025-04-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2016.Additional implant involved: screws: mpact 01.32.6530 cancellous bone screw, flat head ø 6,5 l 30 (k103721) lot.1903942.Batch review performed by medacta regulatory affairs department on 30.Dec.2021: lot 1903942: (b)(4) items manufactured and released on 14-jun-2019.Expiration date: 2024-05-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: screws: mpact 01.32.6520 cancellous bone screw, flat head ø 6,5 l 20 (k103721) lot.2002400.Batch review performed by medacta regulatory affairs department on 30.Dec.2021: lot 2002400: (b)(4) items manufactured and released on 04-jun-2020.Expiration date: 2025-05-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in 1 year and 2 months after the primary surgery due to signs of infection and the pathogen is unknown.The surgeon performed a washout, removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES
• Common Device Name: CEMENTLESS ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13357644
• Report Number: 3005180920-2022-00040
• Device Sequence Number: 16563027
• Product Code: LPH
• UDI-Device Identifier: 07630030810763
• UDI-Public: 07630030810763
• Combination Product (Y/N): N
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2022

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: 11/19/2024
• Device Model Number: 01.32.150DH
• Device Catalogue Number: 01.32.150DH
• Device Lot Number: 1907397
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female