MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DOUBLE MOBILITY SHELLS; CUP: VERSAFITCUP CC 01.26.50MB VERSAFITCUP METALBACK DM Ø50 MM

Model Number	01.26.50MB
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to acetabular cup mobilization and osteolysis related to pe wear at 18 years after primary.
Additional Manufacturer Narrative
Batch review performed on 30 jun 2025: lot 070125: (b)(4) items manufactured and released on 12-apr-2007.Expiration date: 2012-02-28.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.Other device involved: cup: versafitcup cc 01.26.50mb versafitcup metalback dm ø50 mm (k083116) lot 070121: (b)(4) items manufactured and released on 30-april-2007.Expiration date: 2012-03-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation a revision surgery was performed 18 years after the primary total hip arthroplasty implantation.The reported reason for the revision was "wear".Radiographic examination reveals signs consistent with mobilization of the acetabular cup, notably areas of reduced bone density within the acetabulum that may represent osteolysis related to pe wear.On the stem side, small radiolucent areas are present proximally; however, these did not compromise implant stability, and c onsequently the stem was not revised.The observed wear of a standard pe dual-mobility liner after 18 years aligns with common findings reported extensively in medical literature and is not indicative of product defect or malfunction.Analysis performed by r&d manager from the received information, there is an evident material loss in the polar region of the dual mobility polyethylene liner.The origin of the damage is unknown, but it could be probably related to a third body effect.From the received information, there are no information that could help in the root cause of the event; however, being a standard not-crosslinked polyethylene implanted in the patient for 18 years, a wear of the polyethylene liner is a common finding reported in medical literature.Based on the information available no definitive root cause can be established, while 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.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.The dual-mobility liner appeared totally open in the dome, due to the wear caused by the femoral head; the femoral head appeared worn in the polar surface most probably by the rubbing with the acetabular dome.From the received parts it is not possible to determine with certainty the root cause of the event, but a possible presence of third bodies could have caused the wear of the polyethylene liner and the subsequent damage on the metal ball head.As indicated in the clinical evaluation, the observed wear of a standard pe dual-mobility liner after 18 years aligns with common findings reported extensively in medical literature and is not indicative of a product defect or malfunction.Batch review performed on 19 sept 2025 related to the ball head (not registered in us): ball heads: inox 25055.2801 316lvm ball head 12/14 ø28 mm size s lot 070937: (b)(4) items manufactured and released on 20-aug-2007.Expiration date: 2012-08-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Conclusions: although no definitive root cause can be determined, osteolysis may be the consequence of standard polyethylene wear, as commonly described in the literature.It is also likely that a third body was present within the prosthesis, contributing to the wear observed.There is no indication that any device deficiency caused or contributed to the event, and the device history record review did not reveal any potentially related manufacturing issues.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY SHELLS
• Common Device Name: CUP: VERSAFITCUP CC 01.26.50MB VERSAFITCUP METALBACK DM Ø50 MM
• 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: 22520977
• Report Number: 3005180920-2025-00668
• Device Sequence Number: 12919898
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2025

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: 02/28/2012
• Device Model Number: 01.26.50MB
• Device Lot Number: 070121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2007
• 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 Sex: Unknown