MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; VERSAFITCUP METALBACK CC TRIO Ø54 MM

Model Number	01.26.45.0054
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 07 may 2026: cup: versafitcup cc trio 01.26.45.0054 versafitcup metalback cc trio d 54 (k103352) lot 2336854: (b)(4) items manufactured and released on 03-nov-2023.Expiration date: 2028-oct-03.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported events during the period of review.Stem: quadra-p collared 01.12.164 quadra-p collared std.Size 4 (k192827) lot 2346480: (b)(4) items manufactured and released on 27-feb-2024.Expiration date: 2029-feb-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Liner: mectacer 01.29.413 mectacer insert biolox delta xlw18 dia.36/44g (not marketed in us) lot 2414802: (b)(4) items manufactured and released on 10-jun-2024.Expiration date: 2029-may-22.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported events during the period of review.Ball heads: mectacer 01.29.208 mectacer head biolox delta dia.36 12/14-s (k112115) lot 2416429: (b)(4) items manufactured and released on 19-jun-2024.Expiration date: 2029-06-02.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation performed by medacta medical affairs director: less than 2 years after primary cementless tha, the patient reports pain and an infection is detected.As per attached images, the infection has reached the surface of the implants, which are reported to have been found solidly attached to the bone.Given the general conditions of the patient, it is very likely that the infection originated at another site and then extended to the bone/implant interface, but of course, we cannot be sure of this statement.As the devices were solidly attached, we see no reason to suspect that they contributed in any way to the situation that determined their removal.Investigation performed by medacta hip r&d project manager: from the informations and the images received it is visible the explanted stem, cup and heads.All explanted implants are covered with patient blood.It is not possible to identify any anomalies of these implants.The root cause remain unknown.Root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
The patient had a primary hip replacement on (b)(6) 2024.Approximately 8 months ago, the patient reported pain in the right hip area.Investigations confirmed a prosthetic joint infection.On the (b)(6) 2026, the implants were explanted, and a temporary stem and cup were implanted, with planned revision surgery once the infection is resolved.The origin of the infection is not known.The patient has multiple risk factors (comorbidities such as diabetes and morbid obesity) that make finding the origin of the infection difficult.The stem and cup were well fixated, making implant removal prolonged and technically demanding.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: VERSAFITCUP METALBACK CC TRIO Ø54 MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25253489
• Report Number: 3005180920-2026-00472
• Device Sequence Number: 16088287
• Product Code: LZO
• UDI-Device Identifier: 07630030807787
• UDI-Public: 07630030807787
• Combination Product (Y/N): N
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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: 01.26.45.0054
• Device Lot Number: 2336854
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2023
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 130 KG
• Patient Race: White