MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; HOODED PE LINER Ø 32 / E

Model Number	01.26.3244AT
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 feb 2026.Lot 132700: (b)(4) items manufactured and released on 05-aug-2013.Expiration date: 2018-jun-30.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 clinical affairs director.12 years after primary tha on a young female patient, the pe insert is worn and some osteolytic processes were started in the femoral and acetabular regions, which led to revision surgery and removal of the implants.It is very possible and likely that the osteolytic process was caused by pe debris.The young age and very good bone quality of the patient suggest that she is an active person - there are no explanations in the report as to the choice of the surgeon to implant standard pe, in 2014, in such a young patient: it was probably due to unexplained medical reasons.A standard pe insert, implanted in a young and active patient, is likely to start having problems related to abrasive wear as soon as 10 years after surgery, as widely reported in literature.We therefore do not consider this case as a show of malfunction or defect of the implanted device.
Event or Problem Description
Primary surgery was performed in 2014.Ten years later, the patient started to have pain, and on (b)(6) 2026, the patient underwent revision surgery due tosignificant osteolysis.
Additional Manufacturer Narrative
Device returned to medacta on 12 march 2026.Visual inspection performed by r&d project manager: from the received part, it was possible to note the yellowing of the device due to lipidic absorbsion, and the damage caused by the removal with screws and probably other tools.A qc analysis was done on the liner by 3d scans, in order to detect the surface and its deviations from the original 3d model: some deviations with respect to the 3d model were noticed on the inner sphere, showing a deformation most probably caused by wear in the postero-medial area of the internal surface.From the obtained information, the event could be related to wear of the polyethylene liner; anyway, this type of event is common in the acetabular liners made of conventional uhmwpe after a period of 10 years.Clinical evaluation performed by clinical affairs director: 12 years after primary tha on a young female patient, the pe insert is worn and some osteolytic processes were started in the femoral and acetabular regions, which led to revision surgery and removal of the implants.It is very possible and likely that the osteolytic process was caused by pe debris.The young age and very good bone quality of the patient suggest that she is an active person - there are no explanations in the report as to the choice of the surgeon to implant standard pe, in 2014, in such a young patient: it was probably due to unexplained medical reasons.A standard pe insert, implanted in a young and active patient, is likely to start having problems related to abrasive wear as soon as 10 years after surgery, as widely reported in literature.We therefore do not consider this case as a show of malfunction or defect of the implanted device.The punctual dimensional analysis of the insert revealed the absence of destructive wear, as well as consequences of oxidation - this is normal in standard pe sterilized by eto.The damage to the insert in the removal phase does not allow measurement of volumetric wear.The sections that were measured showed the typical concentration of wear in the main direction of loads.Some parts were deformed, probably because of creep, which also justifies the positive discrepancy in some areas.The wear pattern is compatible with what can be expected after 12 years in a young active patient with standard pe, we did not see unexpected anomalous findings.Conclusion: the root cause of the event is attributable to expected long-term wear of a standard pe liner in a young and active patient, leading to polyethylene debris and subsequent osteolytic processes after 12 years in vivo.There is no indication that any issue with the device caused or contributed to the event, and the device history record review does not suggest any manufacturing-related problem.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: HOODED PE LINER Ø 32 / E
• 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: 24558226
• Report Number: 3005180920-2026-00198
• Device Sequence Number: 15686595
• Product Code: LZO
• UDI-Device Identifier: 07630030807558
• UDI-Public: 07630030807558
• Combination Product (Y/N): N
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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 Expiration Date: 06/30/2018
• Device Model Number: 01.26.3244AT
• Device Lot Number: 132700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2013
• 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: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White