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

Model Number 01.26.52MB

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 03/16/2022

Event Type  Injury  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 289168951
• Report Number: 3005180920-2022-00257
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030808098
• UDI-Public: 07630030808098
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White