MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 48/28; VERSAFITCUP DOUBLE MOBILITY LINER

Catalog Number	01.26.2848MHC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 november 2023: lot 2214841: (b)(4) manufactured and released on 29-sep-2022.Expiration date: 2027-09-12.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.Additional implant involved in the event, batch review performed on 21 november 2023: ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot.2204265 lot 2204265: (b)(4) manufactured and released on 15-jun-2022.Expiration date: 2027-06-02.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
Revision surgery at about 1 year after primary hip surgery due to a leg length discrepancy.The surgeon revised the head and liner and the surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 48/28
• Common Device Name: VERSAFITCUP DOUBLE MOBILITY LINER
• 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: 18254304
• Report Number: 3005180920-2023-00968
• Device Sequence Number: 12524133
• Product Code: MEH
• UDI-Device Identifier: 07630030807244
• UDI-Public: 07630030807244
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 12/04/2023

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 Catalogue Number: 01.26.2848MHC
• Device Lot Number: 2214841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2022
• 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: 42 YR
• Patient Sex: Female
• Patient Race: White