MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C; HIP FLAT PE HC LINER

Model Number	01.26.3239HCT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary surgery performed on (b)(6) 2023.First revision surgery performed on (b)(6) 2023 due to joint luxation (medacta not informed because the surgeon was not a medacta client); only head revised with a zimmer xl head.On (b)(6) 2023, the joint luxated again and head liner and cup were revised with a double mobility system.
Additional Manufacturer Narrative
Batch review performed on 26 may 2023.Lot 2216281: (b)(4) manufactured and released on 05-oct-2022.Expiration date: 2027-sep-22.No anomalies found related to the problem.To date, 27 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision 4 months after total hip arthroplasty due to joint luxation in a 64 year old patient.A first revision surgery performed on (b)(6) 2023 due to joint luxation (medacta not informed because the surgeon was not a medacta client); only head revised with a zimmer xl head.Then, the joint luxated again and head liner and cup were revised with a double mobility system.Luxation with a standard, well proven device is normally due to suboptimal component positioning or insufficient soft tissue tension.The report mentions explicitly that the patient was exceptionally lax.The radiographic images provided do not show additional information.No reason to think of a malfunctioning device.Other devices involved: ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115).Lot 2237472: (b)(4) manufactured and released on 24-nov-2022.Expiration date: 2027-nov-08.No anomalies found related to the problem.To date, 180 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: LINER: VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C
• Common Device Name: HIP FLAT PE HC 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: 17170549
• Report Number: 3005180920-2023-00446
• Device Sequence Number: 7038874
• Product Code: LZO
• UDI-Device Identifier: 07630030807541
• UDI-Public: 07630030807541
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K120531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 06/21/2023

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 Model Number: 01.26.3239HCT
• Device Catalogue Number: 01.26.3239HCT
• Device Lot Number: 2216281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2022
• 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: 64 YR
• Patient Sex: Female