MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 52; CEMENTLESS ACETABULAR SHELL

Model Number	01.26.52MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Implants removed about 1 year and 4 months after the primary surgery during stage 1 revision due to suspected infection, implants removed and spacer implanted.Stage 2 (permanent implant) will follow.
Additional Manufacturer Narrative
Batch review performed on 18 march 2022 lot 180894: (b)(4) items manufactured and released on 13-jun-2018.Expiration date: 2023-jun-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional implant involved: liner: versafitcup dm 01.26.2852mhc double mobility hc liner ø 52/28 (k092265) lot.180669.Batch review performed on 21 march 2022.Lot 180669: (b)(4) items manufactured and released on 17-may-2018.Expiration date: 2023-may-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event.Additional implant involved: stem: quadra-h 01.12.022 cementless, ha coated std stem size 2 (k082792) lot.2006171.Batch review performed on 21 march 2022.Lot 2006171: (b)(4) items manufactured and released on 06-oct-2020.Expiration date: 2025-sep-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional implant involved: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.1904637.Batch review performed on 21 march 2022.Lot 1904637: (b)(4) items manufactured and released on 18-sep-2019.Expiration date: 2024-sep-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
Additional Manufacturer Narrative
On (b)(6) 2022 we were informed that stage 2 revision took place on the same day.Cup, liner and head revised, stem was not revised.
Event or Problem Description
Implants removed about 1 year and 4 months after the primary surgery during stage 1 revision due to suspected infection, head, cup, and liner removed and spacer implanted.Permanent implant implanted on (b)(6) 2022, medacta cup implanted, head and liner from competitor.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 52
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• 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: 14099758
• Report Number: 3005180920-2022-00257
• Device Sequence Number: 6370703
• Product Code: MEH
• UDI-Device Identifier: 07630030808098
• UDI-Public: 07630030808098
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

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: 06/05/2023
• Device Model Number: 01.26.52MB
• Device Catalogue Number: 01.26.52MB
• Device Lot Number: 180894
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2018
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White