MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; ACETABULAR SHELL CC TRIO Ø60

Model Number	01.26.45.0060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient with occasional pain, x-rays showed no issue.Some time later, the patient presents with lumbar pain.Ct scan performed: the radiologist enlarged the field and focused on the lower pelvis, revealing an area of periprosthetic metallosis.Puncture was negative, no infection, but blackish liquid was present.About 9 years and 10 months after the primary surgery, the surgeon cleaned the joint and changed the insert and the femoral head.Stem and cup left in situ.
Additional Manufacturer Narrative
Batch review performed on 17 june 2025: lot 130568: (b)(4) items manufactured and released on 27/03/2013.Expiration date: 28/02/2018.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 implant involved, batch review performed on 17 june 2025: stem: quadra-h 01.12.032 quadra stem quadra laterized hap 12/14 s2 (k082792) lot 147206: (b)(4) items manufactured and released on 08/01/2015.Expiration date: 30/11/2019.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.Devices not registered in us: implants from ceramtec 38.49.7179.285.00 head biolox delta dia.36 12/14-m - steril lot.7010923090 sn (b)(6).Implants from ceramtec 38.49.7188.555.20 insert biolox delta xlw18 dia.36/48g - steril lot.7010960062 sn (b)(6).The legal manufacturer (ceramtec) performed the document review and confirmed that the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect or non-conformities regarding sterilisation.Clinical evaluation performed by medical affairs department: a revision surgery was performed approximately ten years after the primary total hip arthroplasty, due to a diagnosis of metallosis.The available radiographic image does not clearly support the reported diagnosis, as the condition was primarily identified through ct and joint aspiration.Metallosis in this type of construct[?]comprising a metal stem, ceramic head, ceramic liner, and uncemented metal acetabular shell[?]is exceedingly rare, though not impossible, and must be due to impingement of the stem and the cup during extreme range of motion.It is, however, unusual that such a condition would not have caused visible damage to the metal components, and that the surgeon decided to leave them in place.Given the limited clinical and diagnostic data available, no definitive conclusions can be drawn at this stage.Conclusion: there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: ACETABULAR SHELL CC TRIO Ø60
• 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: 22369344
• Report Number: 3005180920-2025-00622
• Device Sequence Number: 8025510
• Product Code: LZO
• UDI-Device Identifier: 07630030807817
• UDI-Public: 07630030807817
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• 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): 07/01/2025

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: 02/28/2018
• Device Model Number: 01.26.45.0060
• Device Lot Number: 130568
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2013
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White