MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 48; CEMENTLESS ACETABULAR CUP

Model Number	01.26.48MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At 1 year and 9 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components, and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 02 may 2022.Lot 1910228: (b)(4) items manufactured and released on 05-may-2020.Expiration date: 2025-04-19.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: ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot.1907335.Batch review performed on 02 may 2022.Lot 1907335: (b)(4) items manufactured and released on 21-jan-2020.Expiration date: 2025-01-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event.Additional implant involved: liner: versafitcup dm 01.26.2848mhc double mobility hc liner ø 48/28 (k092265) lot.1910311.Batch review performed on 02 may 2022.Lot 1910311: (b)(4) items manufactured and released on 03-feb-2020.Expiration date: 2025-01-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event.Additional implant involved:stem: sms solid 01.36.044 sms solid stem std size 4 (k181693) lot.182421.Batch review performed on 02 may 2022.Lot 182421: (b)(4) items manufactured and released on 30-may-2018.Expiration date: 2023-05-22.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 Manufacturer Narrative
On 29 june 2022 medacta international become aware that: the surgeon removed the spacer and implanted permanent hardware: medacta head and sleeve, and competitor cup and liner.
Event or Problem Description
On 29 june 2022 medacta international become aware that: the surgeon removed the spacer and implanted permanent hardware: medacta head and sleeve, and competitor cup and liner.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
• 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: 14485453
• Report Number: 3005180920-2022-00386
• Device Sequence Number: 5177109
• Product Code: MEH
• UDI-Device Identifier: 07630030808036
• UDI-Public: 07630030808036
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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: 04/19/2025
• Device Model Number: 01.26.48MB
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 1910228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2020
• 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 Sex: Unknown