MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 50; HIP CEMENTLESS SHELL

Catalog Number	01.26.50MB
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At 1 year and 11 months from the primary, hip revision surgery on the right side due to infection, which caused the loosening of the stem.Explantation of all the components and reimplantation of a m-vizion stem 180mm, body 20/40mm and a versafitcup dm 52 with dmf liner 28 and ceramic ball head 28 m.
Additional Manufacturer Narrative
Batch review performed on 25 april 2024: lot 2007397: (b)(4) items manufactured and released on 02-dec-2020.Expiration date: 2025-11-25.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional devices involved: batch reviews performed on 25 april 2024: liner: versafitcup dm 01.26.2850mhc double mobility hc liner ø 50/28 (k092265) lot 1909377: (b)(4) items manufactured and released on 29-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 other 2 similar reported event during the period of review.Ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot 2114358: (b)(4) items manufactured and released on 07-jan-2022.Expiration date: 2026-12-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Stem: amistem c 01.18.151 cemented std stem size 1 (k103189) lot 2102130: (b)(4) items manufactured and released on 12-may-2021.Expiration date: 2026-04-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.The pe plug implanted in the patient is not marketed in the usa.We performed anyway the batch review, reported here below: mectaplug 01.33.101 mectaplug pe size 1 () lot 2117832: (b)(4) items manufactured and released on 09-march-2022.Expiration date: 2027-02-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs manager: late infection in tha, 1 year and 11 months after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 50
• Common Device Name: HIP CEMENTLESS SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19297228
• Report Number: 3005180920-2024-00318
• Device Sequence Number: 6834462
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2024

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: 11/25/2025
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 2007397
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2020
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 85 KG